Neomycin and polymyxin b sulfates and dexamethasone for dogs

Neo Poly Dex Ophthalmic Suspension 5 ml is a combination of the antibiotics neomycin and polymyxin B and the anti-inflammatory steroid dexamethasone. It is most often used to treat severe conjunctivitis, nonulcerative keratitis and various corneal conditions.

Neo Poly Dex Ophthalmic is a combination of the antibiotics neomycin and polymyxin B and the anti-inflammatory steroid dexamethasone.

Dogs, Cats, and Horses

It is most often used to treat severe conjunctivitis, nonulcerative keratitis and various corneal conditions.

This medication is used to treat conditions involving swelling (inflammation) of the eyes and to treat or prevent bacterial eye infections.

Sandoz, Falcon or other generic brand

-Neomycin -Polymyxin B sulfates -Dexamethasone

5 ml

Serious side effects are not expected when using this medication. However, some burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur. Continue to use the medication and talk to your veterinarian about any side effects that seem unusual or bothersome to your pet.

If overdose contact your nearest pet hospital immediately

Store at room temperature.

Pharmacists are standing by to offer Pet Parent counseling regarding prescription medication purchased from WalmartPetRx before and after dispensing. Pharmacists on duty are available Monday-Friday, 9:30AM - 5:30PM EST and will be on call Saturday 12:00PM - 4:00PM EST for consultation.

Use as directed by your veterinarian.

Main Ingredients

-Neomycin

-Polymyxin B sulfates

-Dexamethasone

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Neo Poly Dex Ophthalmic Suspension 5 ml

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Fluocinolone Topical and Otic Dosage Forms

§ 524.981 [Reserved]

§ 524.981a Fluocinolone cream.

(a) Specifications. The drug contains 0.025 percent fluocinolone acetonide.

(c) Conditions of use in dogs -

(1) Amount. A small amount is applied to the affected area two or three times daily.

(2) Indications for use. For the relief of pruritis and inflammation associated with certain superficial acute and chronic dermatoses. It is used in the treatment of allergic and acute moist dermatitis and for the relief of superficial inflammation caused by chemical burns and physical abrasions.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 62 FR 40932, July 31, 1997; 79 FR 10968, Feb. 27, 2014]

§ 524.981b Fluocinolone solution.

(a) Specifications. The drug contains 0.01 percent fluocinolone acetonide.

(c) Conditions of use in dogs -

(1) Amount. A small amount of solution is applied to the affected area two or three times daily.

(2) Indications for use -

(i) Dogs. For the relief of pruritis and inflammation associated with otitis externa and certain superficial acute and chronic dermatoses.

(ii) Cats. For the relief of pruritis and inflammation associated with acute otitis externa and certain superficial acute and chronic dermatoses.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 62 FR 40932, July 31, 1997; 79 FR 10969, Feb. 27, 2014]

§ 524.981c Fluocinolone and neomycin cream.

(a) Specifications. The drug contains 0.025 percent fluocinolone acetonide and 0.5 percent neomycin sulfate (0.35 percent neomycin base).

(c) Conditions of use in dogs -

(1) Amount. A small amount is applied to the affected area two or three times daily.

(2) Indications for use -

(i) Dogs. For the relief of pruritis and inflammation associated with superficial acute and chronic dermatoses. It is used in the treatment of allergic and acute moist dermatitis and nonspecific dermatoses.

(ii) Dogs and cats. Used in the treatment of wound infections.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 62 FR 40932, July 31, 1997; 79 FR 10969, Feb. 27, 2014]

§ 524.981d Fluocinolone and dimethyl sulfoxide solution.

(a) Specifications. Each milliliter of solution contains 0.01 percent fluocinolone acetonide and 20 percent dimethyl sulfoxide.

(c) Conditions of use in dogs -

(1) Amount. Instill 1 to 2 milliliters into each anal sac following expression of anal sac contents.

(2) Indications for use. For the relief of impaction commonly present in apparently normal anal sacs, for the reversal of inflammatory changes associated with abnormal anal sacs, and to counteract the offensive odor of anal sac secretions.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 10969, Feb. 27, 2014]

§ 524.981e Fluocinolone and dimethyl sulfoxide otic solution.

(a) Specifications. Each milliliter of solution contains 0.01 percent fluocinolone acetonide and 60 percent dimethyl sulfoxide.

(c) Conditions of use in dogs -

(1) Amount. Instill 4 to 6 drops (0.2 milliliter) twice daily into the ear canal for a maximum period of 14 days. The total dosage used should not exceed 17 milliliters.

(2) Indications for use. For the relief of pruritis and inflammation associated with acute and chronic otitis.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 10969, Feb. 27, 2014]

§ 524.998 Fluralaner.

(a) Specifications. Each milliliter of solution contains 280 milligrams (mg) fluralaner.

(c) Conditions of use -

(1) Dogs -

(i) Amount. Administer topically as a single dose every 12 weeks according to the label dosage schedule to provide a minimum dose of 11.4 mg/lb (25 mg/kg) body weight. May be administered every 8 weeks in case of potential exposure to Amblyomma americanum ticks.

(ii) Indications for use. Kills adult fleas; for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations (Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog tick)) for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lb or greater; for the treatment and control of A. americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lb or greater.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats -

(i) Amount. Administer topically as a single dose every 12 weeks according to the label dosage schedule to provide a minimum dose of 18.2 mg/lb (40 mg/kg) body weight. May be administered every 8 weeks in case of potential exposure to D. variabilis ticks.

(ii) Indications for use. Kills adult fleas; for the treatment and prevention of flea infestations (C. felis) and the treatment and control of I. scapularis (black-legged tick) infestations for 12 weeks in cats and kittens 6 months of age and older, and weighing 2.6 lb or greater; for the treatment and control of D. variabilis (American dog tick) infestations for 8 weeks in cats and kittens 6 months of age and older, and weighing 2.6 lb or greater.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[81 FR 67152, Sept. 30, 2016, as amended at 82 FR 43485, Sept. 18, 2017]

§ 524.1001 Fluralaner and moxidectin.

(a) Specifications. Each milliliter of solution contains 280 milligram (mg) fluralaner and 14 mg moxidectin. Each individually packaged tube contains either 112.5 mg fluralaner and 5.6 mg moxidectin; 250 mg fluralaner and 12.5 mg moxidectin; or 500 mg fluralaner and 25 mg moxidectin.

(c) Conditions of use -

(1) Amount. Administer topically as a single dose every 2 months to provide a minimum dose of 18.2 mg/lb (40 mg/kg) fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin.

(2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati, 4th stage larvae, immature adults, and adults) and hookworm (Ancylostoma tubaeforme, 4th stage larvae, immature adults, and adults); kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations (Ixodes scapularis (black-legged tick) and Dermacentor variabilis (American dog tick)) for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[85 FR 18120, Apr. 1, 2020, as amended at 87 FR 58963, Sept. 29, 2022]

§ 524.1005 Furazolidone powder.

(a) Specifications. The product contains either 4 or 10 percent furazolidone in inert dispersing agent and propellant.

(b) Sponsors.

(2) See No. 017135 for use of the 4 percent product as in paragraph (c)(2)(iv) of this section.

(c) Conditions of use -

(1) Amount. Hold container about 6 to 12 inches from the eye or affected area and apply only enough powder to impart a light yellow color.

(2) Indications of use -

(i) Dogs. For treatment or prevention of bacterial infection of superficial wounds, abrasions, lacerations, and pyogenic dermatitis.

(ii) Horses. For treatment or prevention of bacterial infection of superficial wounds, abrasions, lacerations, and following firing (heat or electrocautery).

(iii) [Reserved]

(iv) Horses and ponies. For treatment or prevention of bacterial infection of superficial wounds, abrasions, and lacerations caused by Staphylococcus aureus, Streptococcus spp. and Proteus spp. sensitive to furazolidone.

(3) Limitations. For topical application in horses, ponies, and dogs: Clean affected area thoroughly, apply drug once or twice daily, and repeat treatment as required. Use only as recommended by a veterinarian in treatment of puncture wounds, wounds requiring surgical debridement or suturing, those of a chronic nature involving proud flesh, generalized and chronic infections of the skin, and those skin conditions associated with intense itching. If redness, irritation, or swelling persists or increases, discontinue use and consult a veterinarian. Do not use in horses intended for human consumption.

[45 FR 49543, July 25, 1980, as amended at 50 FR 30153, July 24, 1985; 56 FR 50653, Oct. 8, 1991; 57 FR 31314, July 15, 1992; 60 FR 55659, Nov. 2, 1995; 65 FR 41588, July 6, 2000; 79 FR 10969, Feb. 27, 2014; 82 FR 11508, Feb. 24, 2017]

§ 524.1044 Gentamicin ophthalmic and topical dosage forms.

§ 524.1044a Gentamicin ophthalmic solution.

(a) Specifications. Each milliliter of solution contains gentamicin sulfate equivalent to 3 milligrams of gentamicin.

(c) Conditions of use in dogs and cats -

(1) Amount. Administer 1 or 2 drops into the conjunctival sac 2 to 4 times a day.

(2) Indications for use. For the topical treatment of infections of the conjunctiva caused by susceptible bacteria.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[80 FR 18776, Apr. 8, 2015]

§ 524.1044b Gentamicin and betamethasone otic solution.

(a) Specifications. Each milliliter of solution contains gentamicin sulfate equivalent to 3 milligrams (mg) gentamicin base and betamethasone valerate equivalent to 1 mg betamethasone alcohol.

(c) Conditions of use -

(1) Amounts and indications for use.

(i) For the treatment of acute and chronic otitis externa caused by bacteria sensitive to gentamicin in dogs, instill three to eight drops of solution into the ear canal twice daily for 7 to 14 days.

(ii) For the treatment of infected superficial lesions caused by bacteria sensitive to gentamicin in dogs and cats, apply a sufficient amount of the drug to cover the treatment area twice daily for 7 to 14 days.

(2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[71 FR 13542, Mar. 16, 2006]

§ 524.1044c Gentamicin ophthalmic ointment.

(a) Specifications. Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin.

(c) Conditions of use in dogs and cats -

(1) Amount. Apply approximately a 1/2-inch strip to the affected eye 2 to 4 times a day.

(2) Indications for use. For treatment of conjunctivitis caused by susceptible bacteria.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[69 FR 47363, Aug. 5, 2004, as amended at 77 FR 64717, Oct. 23, 2012; 85 FR 4208, Jan. 24, 2020]

§ 524.1044d Gentamicin and betamethasone ointment.

(a) Specifications. Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin base and betamethasone valerate equivalent to 1 milligram of betamethasone.

(c) Conditions of use in dogs -

(1) Amount -

(i) Otitis externa. Instill 3 to 8 drops into the ear canal twice daily for 7 days.

(ii) Infected superficial lesions. Apply to cover the treatment area twice daily for 7 to 14 days.

(2) Indications for use. For the treatment of acute and chronic otitis externa and infected superficial lesions caused by bacteria sensitive to gentamicin.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[47 FR 26378, June 18, 1982, as amended at 52 FR 7832, Mar. 13, 1987; 79 FR 10969, Feb. 27, 2014]

§ 524.1044e Gentamicin spray.

(a) Specification. Each milliliter of sterile aqueous solution contains gentamicin sulfate equivalent to 1.07 milligrams of gentamicin.

(d) Conditions of use in cattle -

(1) Amount. Hold the sprayer upright 3 to 6 inches from the affected eye, with the opening directed towards the eye, and pump once. Treat once daily for up to 3 days.

(2) Indications for use. For the treatment of pinkeye in cattle (infectious bovine keratoconjunctivitis) caused by Moraxella bovis.

(3) Limitations. Conditions other than bacterial infections of the bovine eye and infectious keratoconjunctivitis caused by Moraxella bovis may produce similar signs. If conditions persists or increases, discontinue use and consult a veterinarian.

[48 FR 41157, Sept. 14, 1983, as amended 52 FR 7833, Mar. 13, 1987; 79 FR 10969, Feb. 27, 2014; 84 FR 32993, July 11, 2019]

§ 524.1044f Gentamicin and betamethasone spray.

(a) Specifications. Each milliliter of spray contains gentamicin sulfate equivalent to 0.57 milligram (mg) gentamicin base and betamethasone valerate equivalent to 0.284 mg betamethasone.

(c) Conditions of use in dogs -

(1) Amount. Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. Administer two spray actuations two to four times daily for 7 days.

(2) Indications for use. For the treatment of infected superficial lesions caused by bacteria susceptible to gentamicin.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[71 FR 13542, Mar. 16, 2006, as amended at 72 FR 5929, Feb. 8, 2007; 74 FR 22822, May 15, 2009; 77 FR 3598, Jan. 25, 2012; 85 FR 4208, Jan. 24, 2020]

§ 524.1044g Gentamicin, betamethasone, and clotrimazole ointment.

(a) Specifications. Each gram (g) of ointment contains gentamicin sulfate equivalent to 3 milligrams (mg) gentamicin base, betamethasone valerate equivalent to 1 mg betamethasone, and 10 mg clotrimazole.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (c) of this section.

(1) No. 000061 for use of 7.5- or 15-gram (g) tubes, 12.5-, 30-, or 215-g bottles.

(2) No. 054925 for use of 7.5- or 15-g tubes; 10-, 15-, 25-, or 215-g bottles.

(3) No. 069043 for use of 10-, 20-, 40-, or 215-g bottles.

(4) No. 025463 for use of 7.5- or 15-g tubes, or 215-g bottles.

(c) Conditions of use in dogs -

(1) Amount. Instill ointment twice daily into the ear canal for 7 consecutive days.

(i) From 7.5- or 15-g tubes; 10-, 12.5-, 15-, 25-, or 30-g bottles: 4 drops for dogs weighing less than 30 pounds (lb) or 8 drops for dogs weighing 30 lb or more.

(ii) From 20-, 40-, or 215-g bottles: 2 drops for dogs weighing less than 30 lb or 4 drops for dogs weighing 30 lb or more.

(ii) From 20- or 215-g bottles: 2 drops for dogs weighing less than 30 lb or 4 drops for dogs weighing 30 lb or more.

(2) Indications for use. For the treatment of acute and chronic canine otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[58 FR 38973, July 21, 1993, as amended at 63 FR 31932, June 11, 1998; 68 FR 42970, July 21, 2003; 70 FR 8291, Feb. 18, 2005; 71 FR 13542, Mar. 16, 2006; 71 FR 16481, Apr. 3, 2006; 71 FR 38261, July 6, 2006; 71 FR 56867, Sept. 28, 2006; 78 FR 17597, Mar. 22, 2013; 79 FR 10969, Feb. 27, 2014; 81 FR 17608, Mar. 30, 2016]

§ 524.1044h Gentamicin, mometasone, and clotrimazole otic suspension.

(a) Specifications. Each gram of suspension contains gentamicin sulfate, United States Pharmacopeia (USP) equivalent to 3 milligram (mg) gentamicin base, mometasone furoate monohydrate or mometasone furoate anhydrous, USP, equivalent to 1 mg mometasone, and 10 mg clotrimazole, USP.

(c) Conditions of use in dogs -

(1) Amount. For dogs weighing less than 30 pounds (lb), instill 4 drops from the 7.5-, 15-, or 30-gram (g) bottle into the ear canal (2 drops from the 215-g bottle) or, for dogs weighing 30 lb or more, instill 8 drops from the 7.5-, 15-, or 30-g bottle into the ear canal (4 drops from the 215-g bottle), once or twice daily for 7 days.

(2) Indications for use. For the treatment of otitis externa caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P. aeruginosa], coagulase-positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[66 FR 712, Jan. 4, 2001, as amended at 68 FR 15370, Mar. 31, 2003; 70 FR 36338, June 23, 2005; 79 FR 10969, Feb. 27, 2014; 81 FR 59134, Aug. 29, 2016]

§ 524.1044i Gentamicin and betamethasone ophthalmic solution.

(a) Specifications. Each milliliter (mL) of solution contains gentamicin sulfate equivalent to 3 milligrams (mg) of gentamicin base and 1 mg betamethasone acetate equivalent to 0.89 mg betamethasone alcohol.

(c) Conditions of use in dogs -

(1) Amount. Instill one or two drops of solution in the conjunctival sac three or four times a day.

(2) Indications for use. For treatment of external eye infections and inflammation.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[75 FR 54492, Sept. 8, 2010, as amended at 80 FR 13230, Mar. 13, 2015]

§ 524.1132 Hydrocortisone, miconazole, and gentamicin otic suspension.

(a) Specifications. Each milliliter (mL) of suspension contains 1.11 milligrams (mg) hydrocortisone aceponate, 17.4 mg miconazole nitrate, and 1.5 mg gentamicin (as gentamicin sulfate).

(c) Conditions of use in dogs -

(1) Amount. Instill 1.0 mL in the affected ear once daily for 5 days.

(2) Indications for use. For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[76 FR 78150, Dec. 16, 2011, as amended at 83 FR 13635, Mar. 30, 2018]

§ 524.1140 Imidacloprid and ivermectin.

(a) Specifications. The product is available in unit applicator tubes containing 0.4, 1.0, 2.5, or 4.0 milliliters (mL). Each mL of solution contains 100 milligrams (mg) imidacloprid and 800 micrograms (µg) ivermectin.

(c) Conditions of Use in Dogs -

(1) Amount. The recommended minimum dosage is 4.5 mg/pound (lb) (10 mg/kilogram (kg)) of imidacloprid and 36.4 µg/lb (80 µg/kg) of ivermectin, topically once a month.

(2) Indications for Use. For the prevention of heartworm disease caused by Dirofilaria immitis; kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis).

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[67 FR 78685, Dec. 26, 2002, as amended at 86 FR 14821, Mar. 19, 2021]

§ 524.1146 Imidacloprid and moxidectin.

(a) Specifications. Each milliliter of solution contains:

(1) 100 milligrams (mg) imidacloprid and 25 mg moxidectin; or

(2) 100 mg imidacloprid and 10 mg moxidectin.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use -

(1) Dogs -

(i) Amount. Topically apply 4.5 mg/lb body weight (10 mg/kg) imidacloprid and 1.1 mg/lb (2.5 mg/kg) moxidectin, once a month.

(ii) Indications for use.

(A) For the prevention of heartworm disease caused by Dirofilaria immitis; and the treatment and control of intestinal roundworms (Toxocara canis and Toxascaris leonina), hookworms (Ancylostoma caninum and Uncinaria stenocephala), and whipworms (Trichuris vulpis); kills adult fleas and treats flea infestations (Ctenocephalides felis).

(B) For treatment of Dirofilaria immitis circulating microfilariae in heartworm-positive dogs and the treatment and control of sarcoptic mange caused by Sarcoptes scabiei var. canis.

(2) Cats -

(i) Amount. Topically apply 4.5 mg/lb body weight (10 mg/kg) imidacloprid and 0.45 mg/lb (1.0 mg/kg) moxidectin, once a month.

(ii) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis; for the treatment and control of ear mite (Otodectes cynotis) infestations, intestinal roundworms (Toxocara cati), and hookworms (Ancylostoma tubaeforme); kills adult fleas and treats flea infestations (Ctenocephalides felis).

(3) Ferrets -

(i) Amount. Topically apply 9.0 mg/lb body weight (20 mg/kg) imidacloprid and 0.9 mg/lb (2 mg/kg) moxidectin, once a month.

(ii) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis; kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations on ferrets.

[72 FR 10597, Mar. 9, 2007, as amended at 78 FR 73698, Dec. 9, 2013; 85 FR 18120, Apr. 1, 2020; 86 FR 13185, Mar. 8, 2021; 86 FR 14821, Mar. 19, 2021; 87 FR 17946, Mar. 29, 2022; 87 FR 58963, Sept. 29, 2022]

§ 524.1193 Ivermectin topical solution.

(a) Specifications. Each milliliter (mL) of solution contains 5 milligrams of ivermectin.

(e) Conditions of use in cattle -

(1) Amount. One mL per 22 pounds (0.5 milligram per kilogram) of body weight applied topically to the back of the animal.

(2) Indications for use.

(i) It is used for the treatment and control of: Gastrointestinal roundworms (adults and fourth-stage larvae) Ostertagia ostertagi (including inhibited stage), Haemonchus placei, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. surnabada, Oesophagostomum radiatum; (adults) Strongyloides papillosus, Trichuris spp.; lungworms (adults and fourth-stage larvae) Dictyocaulus viviparus; cattle grubs (parasitic stages) Hypoderma bovis, H. lineatum; mites Sarcoptes scabiei var. bovis; lice Linognathus vituli, Haematopinus eurysternus, Damalinia bovis, Solenoptes capillatus; and horn flies Haematobia irritans.

(ii) It controls infections and prevents reinfection with O. ostertagi, O. radiatum, H. placei, T. axei, C. punctata, and C. oncophora for 14 days after treatment.

(iii) It controls infections and prevents reinfection with O. radiatum and D. viviparus for 28 days after treatment, C. punctata and T. axei for 21 days after treatment, O. ostertagi, H. placei, C. oncophora, and C. surnabada for 14 days after treatment, and D. bovis for 56 days after treatment.

(3) Limitations. Do not treat cattle within 48 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product on preruminating calves. Do not use on calves to be processed for veal.

[55 FR 50551, Dec. 7, 1990, as amended at 62 FR 38908, July 21, 1997; 62 FR 63271, Nov. 28, 1997; 63 FR 44385, Aug. 19, 1998; 66 FR 13236, Mar. 5, 2001; 66 FR 63165, Dec. 5, 2001; 68 FR 3817, Jan. 27, 2003; 68 FR 4713, Jan. 30, 2003; 69 FR 501, Jan. 6, 2004; 69 FR 62181, Oct. 25, 2004; 71 FR 13542, Mar. 16, 2006; 72 FR 6464, Feb. 12, 2007; 74 FR 36112, July 22, 2009; 75 FR 26648, May 12, 2010; 76 FR 81807, Dec. 29, 2011; 78 FR 17597, Mar. 22, 2013; 78 FR 63872, Oct. 25, 2013; 81 FR 25328, Apr. 28, 2016; 83 FR 13635, Mar. 30, 2018; 84 FR 8974, Mar. 13, 2019; 84 FR 39184, Aug. 9, 2019; 86 FR 13185, Mar. 8, 2021]

§ 524.1195 Ivermectin otic suspension.

(a) Specifications. Each tube contains 0.5 milliliter (mL) of a 0.01 percent suspension of ivermectin.

(c) Conditions of use -

(1) Amount. Administer the contents of one 0.5-mL tube topically into each external ear canal.

(2) Indications for use. For the treatment of adult ear mite (Otodectes cynotis) infestations in cats and kittens 4 weeks of age and older. Effectiveness against eggs and immature stages has not been proven.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[66 FR 7578, Jan. 24, 2001, as amended at 74 FR 26782, June 4, 2009]

§ 524.1200 Kanamycin ophthalmic and topical dosage forms.

§ 524.1200a Kanamycin ophthalmic ointment.

(a) Specifications. Each gram of ointment contains 3.5 milligrams kanamycin activity as kanamycin sulfate.

(c) Conditions of use in dogs -

(1) Amount. Apply a thin film to the affected eye three or four times daily or more frequently if deemed advisable. Treatment should be continued for at least 48 hours after the eye appears normal.

(2) Indications for use. For the treatment of various eye infections (conjunctivitis, blepharitis, dacryocystitis, keratitis, and corneal ulcerations) due to bacteria sensitive to kanamycin. For prophylaxis in traumatic conditions, removal of foreign bodies, and intraocular surgery.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 10969, Feb. 27, 2014]

§ 524.1200b Kanamycin ophthalmic solution.

(a) Specifications. Each milliliter of solution contains 10 milligrams kanamycin activity as kanamycin sulfate.

(c) Conditions of use in dogs -

(1) Amount. Instill a few drops into the affected eye every 3 hours or more frequently if deemed advisable. Administer as frequently as possible for the first 48 hours, after which the frequency of applications may be decreased. Treatment should be continued for at least 48 hours after the eye appears normal.

(2) Indications for use. For the treatment of various eye infections (conjunctivitis, blepharitis, dacryocystitis, keratitis, and corneal ulcerations) due to bacteria sensitive to kanamycin. For prophylaxis in traumatic conditions, removal of foreign bodies, and intraocular surgery.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 10970, Feb. 27, 2014]

§ 524.1204 Kanamycin, amphomycin, and hydrocortisone ointment.

(a) Specifications. Each gram of ointment contains 5 milligrams kanamycin activity as kanamycin sulfate, 5 milligrams of amphomycin activity as the calcium salt, and 10 milligrams of hydrocortisone acetate.

(c) Conditions of use in dogs -

(1) Amount. Apply to the affected areas of the skin at least twice daily. In severe or widespread lesions it may be desirable to apply the ointment more than twice daily. After some improvement is observed, treatment can usually be reduced to once daily.

(2) Indications for use. For the treatment of acute otitis externa, furunculosis, folliculitis, pruritus, anal gland infections, erythema, decubital ulcers, superficial wounds, and superficial abscesses associated with bacterial infections caused by organisms susceptible to one or both antibiotics.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 10970, Feb. 27, 2014]

§ 524.1240 Levamisole.

(a) Specifications. The drug contains 200 milligrams of levamisole per milliliter of diethylene glycol monobutyl ether (DGME) solution.

(d) Conditions of use. Cattle -

(1) Amount. 2.5 milliliters per 110 pounds (10 milligrams of levamisole per kilogram) of body weight as a single dose topically to the back of the animal.

(2) Indications for use. Anthelmintic effective against stomach worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia), and lungworms (Dictyocaulus).

(3) Limitations. Conditions of constant helminth exposure may require retreatment within 2 to 4 weeks after the first treatment. Cattle must not be slaughtered within 9 days following last treatment. Do not administer to dairy animals of breeding age. Do not treat animals before dipping or prior to exposure to heavy rain. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism, and before using in severely debilitated animals.

[52 FR 10887, Apr. 6, 1987, as amended at 53 FR 7504, Mar. 9, 1988; 62 FR 61626, Nov. 19, 1997; 67 FR 78355, Dec. 24, 2002; 79 FR 10970, Feb. 27, 2014]

§ 524.1376 2-Mercaptobenzothiazole solution.

(a) Specifications. The drug contains 1.3 percent 2-mercaptobenzothiazole in a suitable solvent.

(c) Conditions of use -

(1) Amount. Apply twice daily to affected area.

(2) Indications for use. For dogs as an aid in the treatment of hot spots (moist dermatitis) and as first aid for scrapes and abrasions.

(3) Limitations. Clip hair from affected area before applying. If no improvement is seen within 1 week, consult a veterinarian.

[48 FR 15618, Apr. 12, 1983, as amended at 65 FR 50913, Aug. 22, 2000; 68 FR 33381, June 4, 2003]

§ 524.1443 Miconazole.

(a) Specifications.

(1) Each gram of cream contains miconazole nitrate equivalent to 20 milligrams miconazole base.

(2) Each gram of lotion or spray contains miconazole nitrate equivalent to 1 percent miconazole base.

(c) Conditions of use in dogs and cats -

(1) Amount. Apply once daily by rubbing into or spraying a light covering on the infected site and the immediate surrounding vicinity. Continue treatment for 2 to 4 weeks until infection is completely eradicated as determined by appropriate laboratory examination.

(2) Indications for use. For topical treatment of infections caused by Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[71 FR 13542, Mar. 16, 2006]

§ 524.1445 Miconazole, polymixin B, and prednisolone suspension.

(a) Specifications. Each milliliter of suspension contains 23 milligrams (mg) miconazole nitrate, 0.5293 mg polymixin B sulfate, and 5 mg prednisolone acetate.

(c) Conditions of use in dogs -

(1) Amount. Instill five drops in the ear canal twice daily for 7 consecutive days.

(2) Indications for use. For the treatment of canine otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[ 75 FR 4693, Jan. 29, 2010, as amended at 77 FR 46613, Aug. 6, 2012; 81 FR 48703, July 26, 2016]

§ 524.1446 Milbemycin otic solution.

(a) Specifications. Each tube contains 0.25 milliliter of a 0.1 percent solution of milbemycin oxime.

(c) Conditions of use -

(1) Amount. One tube administered topically into each external ear canal.

(2) Indications for use. For the treatment of ear mite (Otodectes cynotis) infestations in cats and kittens 4 weeks of age and older. Effectiveness is maintained throughout the life cycle of the ear mite.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[65 FR 13905, Mar. 15, 2000, as amended at 66 FR 13849, Mar. 8, 2001]

§ 524.1448 Mirtazapine transdermal ointment.

(a) Specifications. Each gram of ointment contains 20 milligrams (mg) mirtazapine.

(c) Conditions of use -

(1) Amount. Administer topically by applying a 1.5 inch ribbon of ointment (approximately 2 mg) on the inner pinna of the cat's ear once daily for 14 days. Alternate the daily application of ointment between the left and right inner pinna of the ears.

(2) Indications for use. For the management of weight loss in cats.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[83 FR 64740, Dec. 18, 2018, as amended at 85 FR 45308, July 28, 2020]

§ 524.1450 Moxidectin.

(a) Specifications. Each milliliter of solution contains:

(1) 5 milligrams (mg) moxidectin (0.5 percent solution).

(2) 25 mg moxidectin (2.5 percent solution).

(d) Conditions of use -

(1) Cattle -

(i) Amount. Administer topically 0.5 mg per kilogram (kg) of body weight.

(ii) Indications for use. Beef and dairy cattle: For treatment and control of internal and external parasites: gastrointestinal roundworms (Ostertagia ostertagi (adult and L4, including inhibited larvae), Haemonchus placei (adult and L4), Trichostrongylus axei (adult and L4), T. colubriformis (adult and L4), Cooperia oncophora (adult and L4), C. pectinata (adult), C. punctata (adult and L4), C. spatulata (adult), C. surnabada (adult and L4), Bunostomum phlebotomum (adult), Oesophagostomum radiatum (adult and L4), Nematodirus helvetianus (adult and L4)); lungworms (Dictyocaulus viviparus (adult and L4)); cattle grubs (Hypoderma bovis, H. lineatum); mites (Chorioptes bovis, Psoroptes ovis (P. communis var. bovis)); lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus, Bovicola (Damalinia) bovis); and horn flies (Haematobia irritans). To control infections and to protect from reinfection with H. placei for 14 days after treatment, O. radiatum and O. ostertagi for 28 days after treatment, and D. viviparus for 42 days after treatment.

(iii) Limitations. A withdrawal period has not been established for this product on preruminating calves. Do not use on calves to be processed for veal. See § 500.25 of this chapter.

(2) Dogs -

(i) Amount. Administer topically a minimum of 1.1 mg per pound (lb) (2.5 mg/kg) of body weight, once monthly using the appropriate preloaded applicator tube.

(ii) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis, as well as the treatment and control of intestinal hookworm (Ancylostoma caninum (adult, immature adult, and L4 larvae) and Uncinaria stenocephala (adult, immature adult, and L4 larvae)), roundworm (Toxocara canis (adult and L4 larvae) and Toxascaris leonina (adult)), and whipworm (Trichuris vulpis (adult)) infections in dogs and puppies that are at least 7 weeks of age and that weigh at least 3 lbs.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[63 FR 14036, Mar. 24, 1998, as amended at 65 FR 36617, June 9, 2000; 66 FR 46370, Sept. 5, 2001. Redesignated at 76 FR 48715, Aug. 9, 2011, as amended at 80 FR 53460, Sept. 4, 2015; 82 FR 21691, May 10, 2017; 86 FR 14821, Mar. 19, 2021]

§ 524.1465 Mupirocin.

(a) Specifications. Each gram of ointment contains 20 milligrams mupirocin.

(c) Conditions of use in dogs -

(1) Amount. Apply twice daily. Treatment should not exceed 30 days.

(2) Indications for use. For the topical treatment of bacterial infections of the skin, including superficial pyoderma, caused by susceptible strains of Staphylococcus aureus and S. intermedius.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[72 FR 18119, Apr. 11, 2007, as amended at 75 FR 79296, Dec. 20, 2010; 78 FR 52854, Aug. 27, 2013; 79 FR 10970, Feb. 27, 2014; 82 FR 11508, Feb. 24, 2017]

§ 524.1484 Neomycin ophthalmic and topical dosage forms.

§ 524.1484b Neomycin, isoflupredone, and tetracaine powder.

(a) Specifications. Each 15-gram insufflator bottle contains 5 milligrams (mg) neomycin sulfate (equivalent to 3.5 mg neomycin base), 1 mg isoflupredone acetate, and 5 mg tetracaine hydrochloride in a powder base.

(c) Conditions of use in horses, dogs, and cats -

(1) Amount. Apply to affected areas as a dusting powder.

(2) Indications for use. For the treatment or as adjunctive therapy of certain ear and skin conditions caused by or associated with neomycin-susceptible organisms and/or allergy; as a superficial dressing applied to minor cuts, wounds, lacerations, abrasions, and for postsurgical application where reduction of pain and inflammatory response is deemed desirable; as a dusting powder following amputation of tails, claws, and dewclaws and following ear trimming, castrating, and such surgical procedures as ovariohysterectomies. For the treatment of acute otitis externa, acute moist dermatitis, and interdigital dermatitis in dogs.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 43 FR 18172, Apr. 28, 1978; 79 FR 10970, Feb. 27, 2014; 85 FR 45308, July 28, 2020]

§ 524.1484c Neomycin, isoflupredone, and tetracaine ointment.

(a) Specifications. The drug contains 5 milligrams of neomycin sulfate (equivalent to 3.5 milligrams of neomycin base), 1 milligram of isoflupredone acetate, and 5 milligrams of tetracaine hydrochloride in each gram of ointment.

(c) Conditions of use in dogs -

(1) Amount. In treatment of otitis externa and other inflammatory conditions of the external ear canal, a quantity of ointment sufficient to fill the external ear canal; may be applied one to three times daily. When used on the skin or mucous membranes, the affected area should be cleansed, and a small amount of the ointment applied and spread or rubbed in gently. The involved area may be treated one to three times a day and these daily applications continued in accordance with the clinical response.

(2) Indications for use. For the treatment of acute otitis externa in dogs and to a lesser degree, chronic otitis externa in dogs. It also is effective in treating anal gland infections and moist dermatitis in the dog and is a useful dressing for minor cuts, lacerations, abrasions, and post-surgical therapy in the horse, cat, and dog. It may also be used following amputation of dewclaws, tails and claws, following ear trimming and castrating operations.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 43 FR 18172, Apr. 28, 1978; 79 FR 10970, Feb. 27, 2014]

§ 524.1484d Neomycin, hydrocortisone, and tetracaine otic ointment.

(a) Specifications. The product contains 5 milligrams of neomycin sulfate, equivalent to 3.5 milligrams of neomycin base, 5 milligrams of hydrocortisone acetate, and 5 milligrams of tetracaine hydrochloride in each gram of ointment.

(c) Conditions of use in dogs and cats -

(1) Amount. Instill a quantity of ointment sufficient to fill the external ear canal; may be applied one to three times daily.

(2) Indications for use. For the treatment of ear canker and other inflammatory conditions of the external ear canal, acute otitis externa and, to a lesser degree, chronic otitis externa.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 49 FR 21922, May 24, 1984; 79 FR 10970, Feb. 27, 2014]

§ 524.1484e Neomycin and polymyxin B ophthalmic solution.

(a) Specifications. Each milliliter of the ophthalmic preparation contains 5.0 milligrams neomycin sulfate (3.5 milligrams neomycin base), and 10,000 Units of polymyxin B sulfate.

(c) Conditions of use in dogs -

(1) Amount. Instill 1 to 2 drops per eye every 6 hours.

(2) Indications for use. For the treatment of bacterial infections associated with topical ophthalmological conditions such as corneal injuries, superficial keratitis, conjunctivitis, keratoconjunctivitis, and blepharitis.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 61 FR 5507, Feb. 13, 1996; 79 FR 10970, Feb. 27, 2014]

§ 524.1484f Neomycin, prednisolone, and tetracaine otic suspension.

(a) Specifications. The product contains 5 milligrams of neomycin sulfate equivalent to 3.5 milligrams of neomycin base, 2.5 milligrams of prednisolone acetate, and 5 milligrams of tetracaine hydrochloride in each milliliter of sterile suspension.

(c) Conditions of use in dogs and cats -

(1) Amount. Instill 2 to 6 drops in the external ear canal 2 or 3 times daily.

(2) Indications for use. For the treatment of acute otitis externa and, to a lesser degree, chronic otitis externa; as treatment or adjunctive therapy of certain ear conditions caused by or associated with neomycin-susceptible organisms and/or allergy.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 79 FR 10971, Feb. 27, 2014]

§ 524.1484g Neomycin, thiabendazole, and dexamethasone solution.

(a) Specifications. Each milliliter of solution contains 40 milligrams (mg) thiabendazole, 3.2 mg neomycin (from neomycin sulfate), and 1 mg dexamethasone.

(c) Conditions of use in dogs and cats -

(1) Amount. In treating dermatoses affecting areas other than the ear, the surface of the lesions should be well moistened (2 to 4 drops per square inch) twice daily. In treating otitis externa, instill 5 to 15 drops in the ear twice daily. Treat for up to 7 days.

(2) Indications for use. As an aid in the treatment of bacterial, mycotic, and inflammatory dermatoses and otitis externa.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 62 FR 63271, Nov. 28, 1997; 79 FR 10971, Feb. 27, 2014; 80 FR 61297, Oct. 13, 2015; 84 FR 39184, Aug. 9, 2019]

§ 524.1484h Neomycin, penicillin, polymyxin B, and hydrocortisone suspension.

(a) Specifications. Each milliliter of suspension contains 25 milligrams of neomycin sulfate equivalent to 17.5 milligrams of neomycin, 10,000 international units of penicillin G procaine, 5,000 international units of polymyxin B sulfate, 2 milligrams of hydrocortisone acetate, and 1.25 milligrams of hydrocortisone sodium succinate.

(c) Conditions of use in dogs -

(1) Amount. Rub a small amount into the affected area 1 to 3 times a day. After definite improvement, apply once daily or every other day.

(2) Indications for use. For the treatment of summer eczema, atopic dermatitis, interdigital eczema, and otitis externa caused by bacteria susceptible to neomycin, penicillin, and polymyxin B.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use - dogs -

(1) Amount. Rub a small amount into the involved area 1 to 3 times a day. After definite improvement, it may be applied once a day or every other day.

(2) Indications for use. Treatment of summer eczema, atopic dermatitis, interdigital eczema, and otitis externa caused by bacteria susceptible to neomycin, penicillin, and polymyxin B.

(3) Limitations. For use in dogs only. Shake drug thoroughly and clean lesion before using. If redness, irritation, or swelling persists or increases, discontinue use and reevaluate diagnosis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[59 FR 5105, Feb. 3, 1994, as amended at 79 FR 10971, Feb. 27, 2014]

§ 524.1484i Neomycin and hydrocortisone ointment.

(a) Specifications. The drug contains 5 milligrams of neomycin sulfate, equivalent to 3.5 milligrams of neomycin base, and 5 milligrams of hydrocortisone acetate in each gram of ointment.1

(c) Conditions of use in dogs and cats -

(1) Amount. Apply 3 or 4 times daily into the conjunctival sac. With improvement, frequency may be reduced to 2 or 3 times daily. For treatment of ear canker and other inflammatory conditions of the external ear canal, fill external ear canal 1 to 3 times daily.

(2) Indications for use. For the treatment of infections, allergic and traumatic keratitis, conjunctivitis, acute otitis externa and, to a lesser degree, chronic otitis externa.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[43 FR 40456, Sept. 12, 1978, as amended at 79 FR 10971, Feb. 27, 2014]

§ 524.1484j Neomycin and prednisolone ophthalmic ointment.

(a) Specifications. Each gram of ointment contains prednisolone sodium phosphate equivalent to 2.5 milligrams prednisolone 21-phosphate and 5 milligrams neomycin sulfate equivalent to 3.5 milligrams neomycin base.

(c) Conditions of use in dogs and cats -

(1) Amount. A small quantity of the ointment should be expressed into the conjunctival sac 4 times a day (at intervals of 1 to 8 hours) for a few days until there is a favorable response, then the frequency of application may be reduced to twice daily as long as the condition remains under control. Treatment may require from a few days to several weeks.

(2) Indications for use. For use in superficial ocular inflammations or infections limited to the conjunctiva or the anterior segment of the eye, such as those associated with allergic reactions or gross irritants.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 10971, Feb. 27, 2014, as amended at 84 FR 39184, Aug. 9, 2019]

§ 524.1484k Neomycin and prednisolone suspension.

(a) Specifications. Each milliliter of suspension contains 2.5 milligrams of prednisolone acetate and 5 milligrams of neomycin sulfate equivalent to 3.5 milligrams of neomycin base.

(c) Conditions of use in dogs and cats -

(1) Amount. For beginning treatment of acute ocular inflammations place 1 or 2 drops in the conjunctival sac 3 to 6 times during a 24 hour period. When improvement occurs, reduce the dosage to 1 drop 2 to 4 times daily. For otitis externa, place 2 to 6 drops in the external ear canal 2 or 3 times daily.

(2) Indications for use. For the treatment of treating infectious, allergic and traumatic keratitis and conjunctivitis, acute otitis externa, and chronic otitis externa.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 10971, Feb. 27, 2014]

§ 524.1580 Nitrofurazone topical dosage forms.

§ 524.1580a Nitrofurazone ointment.

(a) Specifications. The drug contains 0.2 percent nitrofurazone in a water-soluble base.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter.

(1) See Nos. 054925, 058005, 059051, 061133, and 069043 for use on dogs, cats, or horses.

(2) See No. 017135 for use on dogs and horses.

(3) See Nos. 017153 and 058829 for use on horses.

(c) [Reserved]

(d) Conditions of use -

(1) Amount. Apply directly on the lesion with a spatula or first place on a piece of gauze. The preparation should remain on the lesion for at least 24 hours. Use of a bandage is optional.

(2) Indications for use. For prevention or treatment of surface bacterial infections of wounds, burns, and cutaneous ulcers of dogs, cats, or horses.

(3) Limitations. For use only on dogs, cats, and horses. Do not use on horses intended for human consumption. Federal law prohibits the use of this product in food-producing animals. In case of deep or puncture wounds or serious burns, use only as recommended by veterinarian. If redness, irritation, or swelling persists or increases, discontinue use; consult veterinarian.

[46 FR 43402, June 27, 1980. Redesignated at 79 FR 10971, Feb. 27, 2014]

§ 524.1580b Nitrofurazone soluble powder.

(a) Specifications. The drug contains 0.2 percent nitrofurazone in a water-soluble base.

(c) Conditions of use -

(1) Amount. Apply several times daily to the lesion or affected area from the plastic squeeze bottle.

(2) Indications for use. For prevention or treatment of surface bacterial infections of wounds, burns, skin ulcers, and abscesses after incision.

(3) Limitations. In case of deep or puncture wounds or serious burns, use only as recommended by veterinarian. If redness, irritation, or swelling persists or increases, discontinue use; consult veterinarian. For use only on dogs, cats, and horses (not for food use).

[45 FR 43402, June 27, 1980, as amended at 47 FR 43368, Oct. 1, 1982; 48 FR 28984, June 24, 1983; 53 FR 40728, Oct. 18, 1988; 54 FR 30542, July 21, 1989; 56 FR 50653, Oct. 8, 1991; 59 FR 33197, June 28, 1994; 60 FR 55659, Nov. 2, 1995; 62 FR 35077, June 30, 1997; 76 FR 17778, Mar. 31, 2011; 78 FR 21060, Apr. 9, 2013. Redesignated at 79 FR 10971, Feb. 27, 2014, as amended at 79 FR 64117, Oct. 28, 2014; 83 FR 48947, Sept. 28, 2018]

§ 524.1580c Nitrofurazone and butacaine ointment.

(a) Specifications. The drug contains 0.2 percent nitrofurazone and 0.5 percent butacaine sulfate in a water-soluble base.

(c) Conditions of use -

(1) Indications for use. For prevention or treatment of surface bacterial infections of ears, wounds, burns, and cutaneous ulcers of dogs, cats, and horses.

(2) Limitations. Apply directly on the lesion with a spatula or first place on a piece of gauze. Use of a bandage is optional. The preparation should remain on the lesion for at least 24 hours. The dressing may be changed several times daily or left on the lesion for a longer period. For use only on dogs, cats, and horses (not for food use). In case of deep or puncture wounds or serious burns, use only as recommended by a veterinarian. If redness, irritation, or swelling persists or increases, discontinue use; consult veterinarian.

[49 FR 9417, Mar. 13, 1984, as amended at 71 FR 13542, Mar. 16, 2006. Redesignated at 79 FR 10971, Feb. 27, 2014; 79 FR 10971, Feb. 27, 2014]

§ 524.1600 Nystatin ophthalmic and topical dosage forms.

§ 524.1600a Nystatin, neomycin, thiostrepton, and triamcinolone ointment.

(a) Specifications. Each milliliter of petrolatum base or each gram of vanishing cream base ointment contains: 100,000 units of nystatin; neomycin sulfate equivalent to 2.5 milligrams of neomycin base; 2,500 units of thiostrepton; and 1.0 milligram of triamcinolone acetonide.

(b) Sponsors. For petrolatum base ointments see Nos. 000856, 025463, 054771, and 054925 in § 510.600(c) of this chapter. For vanishing cream base ointments see Nos. 025463, 054771, and 054925.

(c) Conditions of use -

(1) Amount.

(i) For topical dermatological use: Clean affected areas and remove any encrusted discharge or exudate, and apply sparingly either ointment in a thin film.

(ii) For otic use: Clean ear canal of impacted cerumen, remove any foreign bodies such as grass awns and ticks, and instill three to five drops of petrolatum base ointment. Preliminary use of a local anesthetic may be advisable.

(iii) For infected anal glands and cystic areas: Drain gland or cyst and fill with petrolatum base ointment.

(2) Indications for use.

(i) Topically: Use either ointment in dogs and cats for anti-inflammatory, antipruritic, antifungal, and antibacterial treatment of superficial bacterial infections, and for dermatologic disorders characterized by inflammation and dry or exudative dermatitis, particularly associated with bacterial or candidal (Candida albicans) infections.

(ii) Otitis, cysts, and anal gland infections: Use petrolatum base ointment in dogs and cats for the treatment of acute and chronic otitis and interdigital cysts, and in dogs for anal gland infections.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 43 FR 29770, July 11, 1978; 50 FR 41490, Oct. 11, 1985; 53 FR 39257, Oct. 6, 1988; 54 FR 5431, Feb. 3, 1989; 54 FR 48090, Nov. 21, 1989; 56 FR 50653, Oct. 8, 1991; 60 FR 55660, Nov. 2, 1995; 61 FR 63712, Dec. 2, 1996; 64 FR 42831, Aug. 6, 1999; 67 FR 67521, Nov. 6, 2002; 68 FR 55201, Sept. 23, 2003; 70 FR 50183, Aug. 26, 2005; 71 FR 13542, Mar. 16, 2006; 79 FR 10972, Feb. 27, 2014]

§ 524.1600b Nystatin, neomycin, thiostrepton, and triamcinolone ophthalmic ointment.

(a) Specifications. Each cubic centimeter of ointment contains: 100,000 units of nystatin, neomycin sulfate equivalent to 2.5 milligrams of neomycin base, 2,500 units of thiostrepton, and 1.0 milligram of triamcinolone acetonide.

(d) Conditions of use -

(1) Dogs and cats -

(i) Amount. Apply 1 drop of ointment to the affected eye(s) 2 or 3 times daily. Treatment may be continued for up to 2 weeks if necessary.

(ii) Indications for use. For use as an anti-inflammatory, antipruritic, antifungal (Candida albicans), and antibacterial ointment for local therapy in keratitis and conjunctivitis.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cattle -

(i) Amount. Apply small line of ointment to the affected eye(s) once daily. Treatment may be continued for up to 2 weeks if necessary.

(ii) Indications for use. For infectious kerato-conjunctivitis (pinkeye).

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 50 FR 41490, Oct. 11, 1985; 79 FR 10972, Feb. 27, 2014; 84 FR 32993, July 11, 2019]

§ 524.1610 Orbifloxacin, mometasone furoate monohydrate, and posaconazole suspension.

(a) Specifications. Each gram of suspension contains 10 milligrams (mg) orbifloxacin, mometasone furoate monohydrate equivalent to 1 mg mometasone furoate, and 1 mg posaconazole.

(c) Conditions of use in dogs -

(1) Amount. For dogs weighing less than 30 lbs. instill 4 drops once daily into the ear canal. For dogs weighing 30 lbs. or more, instill 8 drops into the ear canal. Therapy should continue for 7 consecutive days.

(2) Indications for use. For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (coagulase-positive staphylococci, Pseudomonas aeruginosa, and Enterococcus faecalis).

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[75 FR 16346, Apr. 1, 2010]

§ 524.1662 Oxytetracycline ophthalmic and topical dosage forms.

§ 524.1662a Oxytetracycline and hydrocortisone spray.

(a) Specifications. Each 3-ounce unit of oxytetracycline hydrochloride and hydrocortisone spray contains 300 milligrams of oxytetracycline hydrochloride and 100 milligrams of hydrocortisone with an inert freon propellant such that a 1-second spray treatment will deliver approximately 2.5 milligrams of oxytetracycline hydrochloride and 0.8 milligram of hydrocortisone.

(c) Conditions of use in dogs and cats -

(1) Amount. A small quantity should be sprayed on the affected surface by holding the container about 6 inches from the area to be treated and pressing the nozzle for 1 or 2 seconds. Only sufficient spray to coat the skin thinly is necessary. The application of small amounts at frequent intervals will give best results. Before treating animals with long or matted hair, it may be necessary to clip the affected area or spread the hairs to allow the medication to contact the skin surface. Relief may be noted following the first or second treatment; however, treatment should not be discontinued too soon after the initial favorable response has been obtained.

(2) Indications for use. For the relief of discomfort and continued treatment of many allergic, infectious, and traumatic skin conditions; for the prevention of bacterial infections in superficial wounds, cuts, and abrasions, treatment of allergic dermatoses, including urticaria, eczemas, insect bites, and cutaneous drug reactions, infections associated with minor burns and wounds, and nonspecific pruritus.

(3) Limitations. Keep away from eyes or other mucous membranes; avoid inhaling; use with adequate ventilation; in case of deep or puncture wounds or serious burns, consult a veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 79 FR 10972, Feb. 27, 2014]

§ 524.1662b Oxytetracycline and polymyxin B ophthalmic ointment.

(a) Specifications. Each gram of the ointment contains oxytetracycline hydrochloride equivalent to 5 milligrams of oxytetracycline and 10,000 units of polymyxin B sulfate.

(c) Conditions of use in dogs and cats -

(1) Amount. Administer topically to the eye two to four times daily.

(2) Indications for use. For the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline- and polymyxin-sensitive organisms including ocular infections due to streptococci, rickettsiae, E. coli, and A. aerogenes (such as conjunctivitis, keratitis, pinkeye, corneal ulcer, and blepharitis in dogs, cats, cattle, sheep, and horses); ocular infections due to secondary bacterial complications associated with distemper in dogs; and ocular infections due to bacterial inflammatory conditions which may occur secondary to other infectious diseases in dogs, cats, cattle, sheep, and horses.

(3) Limitations. Allergic reactions may occasionally occur. Treatment should be discontinued if reactions are severe. If new infections due to nonsensitive bacteria or fungi appear during therapy, appropriate measures should be taken.

[40 FR 13873, Mar. 27, 1975, as amended at 79 FR 10972, Feb. 27, 2014]

§ 524.1742 Phosmet emulsifiable liquid.

(a) Specifications. The emulsifiable liquid contains 11.6 percent N-(mercaptomethyl) phthalimide S-(O,O- dimethyl phosphorodithioate).

(d) Conditions of use -

(1) Methods of application. Methods of application to control the following conditions on beef cattle:

Table 1 to Paragraph (d)(1)

(i) Dip vat procedure.

(A) Prior to charging vat, empty old contents and thoroughly clean the vat. Dip vats should be calibrated to maintain an accurate dilution. Add water, then drug to the vat according to the dilution rate indicated in the table. Add super phosphate at a rate of 100 pounds per 1,000 gallons of vat solution. Super phosphate is added to control the pH of the solution and ensure vat stability. Super phosphate is usually available at most fertilizer dealers as 0-45-0 or 0-46-0. Stir the dip thoroughly, preferably with a compressed air device; however, any form of thorough mixing is adequate. Re-stir vat contents prior to each use. During the dipping operation, each time the dip's volume is reduced by 1⁄8 to 1⁄4 of its initial volume, replenish with water and add the drug at a rate of 1 gallon for each 50 or 200 gallons water added - depending on dilution rate 1:60 or 1:240. Also add super phosphate as necessary to maintain pH between 4.5 and 6.5. Stir well and resume dipping. Repeat replenishment process as necessary. For evaportion, add additional water accordingly. For added water due to rainfall, merely replenish dip with the product according to directions. If overflow occurs, either analyze for drug concentration and adjust accordingly or dispose of vat contents and recharge. Check pH after each addition of water or super phosphate to assure proper pH controls.

(B) Dip maintenance.

(1) With use of dip vat tester, dipping may continue as long as the drug concentration is maintained between 0.15 and 0.25 percent, and the dip is not too foul for satisfactory use as indicated by foul odor or excessive darkening (i.e., color changes from beige to very dark brown).

(2) Without use of dip vat tester, vat should be emptied, cleaned, and recharged each time one of the following occurs: When the dip has been charged for 120 days; when the dip becomes too foul for satisfactory use, within the 120-day limit; if the number of animals dipped equals twice the number of gallons of the initial dip volume, within the 120-day limit.

(ii) Spray method. To prepare the spray, mix drug with water according to table and stir thoroughly. Apply the fresh mixture as a high-pressure spray, taking care to wet the skin, not just the hair. Apply to the point of “runoff,” about 1 gallon of diluted spray per adult animal. Lesser amounts will permit runoff for younger animals.

(iii) Pour-on method. Dilute the drug with water according to table by slowly adding water to the product while stirring. Apply 1 ounce of the diluted mixture per 100 pounds of body weight (to a maximum of 8 ounces per head) down the center line of the back.

(2) Timing of applications for cattle grub control. For optimum cattle grub control, it is important to treat as soon as possible after the heel fly season, before the grub larvae reach the gullet or spinal canal, as the rapid kill of large numbers of larvae in these tissues may cause toxic side effects, such as bloat, salivation, staggering, and paralysis.

(3) Treatment regimens.

(i) Control of scabies mites requires two treatments, 10 to 14 days apart.

(ii) Control of Lone Star Ticks and hornflies requires two treatments, 7 days apart.

(4) Warnings. The drug is a cholinesterase inhibitor. Do not use this drug on animals simultaneously or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals. Do not apply within 21 days of slaughter. For use on beef cattle only. Do not treat sick, convalescent, or stressed cattle, or calves less than 3 months old except in Federal or State eradication programs where immediate treatment of all animals in an infested herd is mandatory. Be sure free access to drinking water is available to cattle prior to dipping. Do not dip excessively thirsty animals. Do not dip animals when overheated. Repeat treatment as necessary but not more often than every 7 to 10 days. Treatment for lice, ticks, hornflies, and scabies mites may be made any time of the year except when cattle grub larvae are in the gullet or spinal canal. Treatment for lice, ticks, and scabies mites may be made any time 7 to 10 days following treatment for grubs. Do not treat grubs when the grub larvae are in the gullet or spinal canal. Do not get in eyes, on skin, or on clothing. Do not breathe spray mist. Wear rubber gloves, goggles, and protective clothing. In case of skin contact, wash immediately with soap and water; for eyes, flush with water. Wash all contaminated clothing with soap and hot water before re-use.

[40 FR 13873, Mar. 27, 1975, as amended at 46 FR 27914, May 22, 1981; 48 FR 39607, Sept. 1, 1983; 54 FR 51021, Dec. 12, 1989; 61 FR 8873, Mar. 6, 1996; 62 FR 61626, Nov. 19, 1997; 63 FR 5255, Feb. 2, 1998; 85 FR 18120, Apr. 1, 2020]

§ 524.1982 Proparacaine ophthalmic solution.

(a) Specifications. The drug is an aqueous solution containing 0.5 percent proparacaine hydrochloride, 2.45 percent glycerin as a stabilizer, and 0.2 percent chlorobutanol (choral derivative) and 1:10,000 benzalkonium chloride as preservatives.

(c) Conditions of use in dogs and cats -

(1) Amount. It is administered as follows:

(i) For removal of sutures: Instill one to two drops 2 or 3 minutes before removal of stitches.

(ii) For removal of foreign bodies from eye, ear, and nose: For ophthalmic use, instill three to five drops in the eye prior to examination; for otic use, instill five to ten drops in the ear; for nasal use, instill five to ten drops in each nostril every 3 minutes for three doses.

(iii) For tonometry: Instill one to two drops immediately before measurement.

(iv) As an aid in treatment of otitis: Instill two drops into the ear every 5 minutes for three doses.

(v) For minor surgery: Instill one or more drops as required.

(vi) For catheterization: Instill two to three drops with a blunt 20-gauge needle immediately before inserting catheter.

(2) Indications for use. For use as a topical ophthalmic anesthetic. It is used as an anesthetic in cauterization of corneal ulcers, removal of foreign bodies and sutures from the cornea, and measurement of intraocular pressure (tonometry) when glaucoma is suspected; as an aid in the removal of foreign bodies from the nose and ear canal; as an accessory in the examination and treatment of painful otitis, in minor surgery, and prior to catheterization.

(3) Limitations. Keep away from eyes or other mucous membranes; avoid inhaling; use with adequate ventilation; in case of deep or puncture wounds or serious burns, consult a veterinarian.

(d) Conditions of use.

(1) The drug is indicated for use as a topical ophthalmic anesthetic in animals. It is used as an anesthetic in cauterization of corneal ulcers, removal of foreign bodies and sutures from the cornea, and measurement of intraocular pressure (tonometry) when glaucoma is suspected. Local applications may also be used as an aid in the removal of foreign bodies from the nose and ear canal, as an accessory in the examination and treatment of painful otitis, in minor surgery, and prior to catheterization.

(2) It is administered as follows:

(i) For removal of sutures: Instill one to two drops 2 or 3 minutes before removal of stitches.

(ii) For removal of foreign bodies from eye, ear, and nose: For ophthalmic use, instill three to five drops in the eye prior to examination; for otic use, instill five to 10 drops in the ear; for nasal use, instill five to 10 drops in each nostril every 3 minutes for three doses.

(iii) For tonometry: Instill one to two drops immediately before measurement.

(iv) As an aid in treatment of otitis: Instill two drops into the ear every 5 minutes for three doses.

(v) For minor surgery: Instill one or more drops as required.

(vi) For catheterization: Instill two to three drops with a blunt 20-gauge needle immediately before inserting catheter.

(3) For use only by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 50 FR 41490, Oct. 11, 1985; 79 FR 10972, Feb. 27, 2014]

§ 524.2080 Ropinirole.

(a) Specifications. Each milliliter of solution contains 30 milligrams (mg) ropinirole (equivalent to 34.2 mg ropinirole hydrochloride).

(c) Conditions of use -

(1) Amount. Using the table provided in labeling, administer the number of eye drops topically, corresponding to body weight, that results in a target dose of 3.75 mg per square meter (mg/m2) (dose band 2.7 to 5.4 mg/m2). If the dog does not vomit within 20 minutes of the first dose, then a second dose may be administered.

(2) Indications for use. For the induction of vomiting in dogs.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[86 FR 13185, Mar. 8, 2021]

§ 524.2098 Selamectin.

(a) Specifications. Each milliliter contains 60 or 120 milligrams (mg) of selamectin.

(c) Conditions of use -

(1) Amount. Administer topically 2.7 mg of selamectin per pound (6 mg per kilogram) of body weight.

(2) Indications for use. Kills adult fleas and prevents flea eggs from hatching for 1 month, and it is indicated for the prevention and control of flea infestations (Ctenocephalides felis), prevention of heartworm disease caused by Dirofilaria immitis, and treatment and control of ear mite (Otodectes cynotis) infestations in dogs and cats. Treatment and control of sarcoptic mange (Sarcoptes scabiei) and control of tick (Dermacentor variabilis) infestations in dogs. Treatment and control of intestinal hookworm (Ancylostoma tubaeforme) and roundworm (Toxocara cati) infections in cats. For dogs 6 weeks of age and older, and cats 8 weeks of age and older.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[64 FR 37401, July 12, 1999, as amended at 64 FR 48707, Sept. 8, 1999; 65 FR 45282, July 21, 2000; 74 FR 19878, Apr. 30, 2009; 79 FR 10972, Feb. 27, 2014; 86 FR 17064, Apr. 1, 2021; 87 FR 58963, Sept. 29, 2022]

§ 524.2099 Selamectin and sarolaner.

(a) Specifications. Each milliliter (mL) of solution contains 60 milligrams (mg) selamectin and 10 mg sarolaner. The drug is provided in single dose tubes containing 0.25, 0.5, or 1 mL of solution.

(c) Conditions of use in cats -

(1) Amount. Administer 2.7 mg selamectin per pound (/lb) (6 mg per kilogram (/kg)) of body weight and 0.45 mg/lb sarolaner (1 mg/kg) by emptying the contents of the tube on the back of the animal at the base of the neck in front of the shoulder blades.

(2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis. Kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations; the treatment and control of tick infestations with Ixodes scapularis (black-legged or deer tick), Amblyomma maculatum (Gulf Coast tick), and Dermacentor variabilis (American dog tick); the treatment and control of ear mite (Otodectes cynotis) infestations; and the treatment and control of roundworm (Toxocara cati) and intestinal hookworm (Ancylostoma tubaeforme) infections in cats and kittens 8 weeks of age and older, and weighing 2.8 pounds or greater.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[84 FR 12494, Apr. 2, 2019]

§ 524.2101 Selenium disulfide suspension.

(a) Specifications. The product contains 0.9-percent weight in weight (w/w) selenium disulfide (1-percent weight in volume (w/v)).

(c) Conditions of use on dogs -

(1) Indications for use. For use as a cleansing shampoo and as an agent for removing skin debris associated with dry eczema, seborrhea, and nonspecific dermatoses.

(2) Amount. One to 2 ounces per application.

(3) Limitations. Use carefully around scrotum and eyes, covering scrotum with petrolatum. Allow the shampoo to remain for 5 to 15 minutes before thorough rinsing. Repeat treatment once or twice a week. If conditions persist or if rash or irritation develops, discontinue use and consult a veterinarian.

[47 FR 53351, Nov. 26, 1982, as amended at 48 FR 32762, July 19, 1983; 54 FR 36962, Sept. 6, 1989; 56 FR 9623, Mar. 7, 1991; 58 FR 41025, Aug. 2, 1993; 63 FR 26981, May 15, 1998; 70 FR 50183, Aug. 26, 2005; 84 FR 39184, Aug. 9, 2019]

§ 524.2350 Tolnaftate cream.

(a) Specifications. The drug contains 1 percent tolnaftate in an anhydrous cream base.

(c) Conditions of use -

(1) Amount. Apply a small amount of the cream to the affected areas once or twice a day for 2 to 4 weeks.

(2) Indications for use. For the treatment of ringworm lesions due to Microsporum canis and Microsporum gypseum.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 10972, Feb. 27, 2014]

§ 524.2482 Triamcinolone spray.

(a) Specifications. Each milliliter of solution contains 0.15 milligrams triamcinolone acetonide.

(c) Conditions of use in dogs -

(1) Amount. Apply sufficient pump sprays to uniformly and thoroughly wet the affected areas while avoiding run off of excess product. Administer twice daily for 7 days, then once daily for 7 days, then every other day for an additional 14 days (28 days total).

(2) Indications for use. For the control of pruritus associated with allergic dermatitis.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[68 FR 4916, Jan. 31, 2003, as amended at 78 FR 17868, Mar. 25, 2013]

§ 524.2483 Triamcinolone cream.

(a) Specifications. The vanishing cream contains 0.1 percent triamcinolone acetonide.

(c) Conditions of use in dogs -

(1) Amount. Rub into affected areas two to four times daily for 4 to 10 days.

(2) Indications for use. For topical treatment of allergic dermatitis and summer eczema.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[71 FR 13542, Mar. 16, 2006, as amended at 73 FR 79318, Dec. 29, 2008. Redesignated and amended at 75 FR 10168, Mar. 5, 2010; 77 FR 60302, Oct. 3, 2012]

§ 524.2620 Liquid crystalline trypsin, Peru balsam, castor oil.

(a) Specifications.

(1) Each gram of liquid or aerosol contains 0.12 milligram of crystalline trypsin, 87.0 milligrams of Peru balsam, and 788.0 milligrams of castor oil.

(2) Each gram of liquid or aerosol contains 0.1 milligram of crystalline trypsin, 72.5 milligrams of Peru balsam, and 800 milligrams of castor oil.

(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use as in paragraph (c) in this section:

(1) No. 051079 for use of product described in paragraph (a)(1).

(2) No. 017135 for use of product described in paragraph (a)(2).

(c) Conditions of use -

(1) Amount. Apply directly to the wound site.

(2) Indications for use. As an aid in the treatment of external wounds and assists healing by facilitating the removal of necrotic tissue, exudate, and organic debris.

[79 FR 10973, Feb. 27, 2014]

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