Title 21 CFR reference

Specifications.(a) Each gram of ointment contains: (1) 500 units bacitracin, 3.5 milligrams (mg) neomycin sulfate (equivalent to 3.5 mg neomycin base), and 10,000 units polymyxin B sulfate; or (2) 400 units bacitracin zinc, 5 mg neomycin sulfate (equivalent to 3.5 mg neomycin base), and 10,000 units polymyxin B sulfate. Sponsors.(b) See sponsor numbers in § 510.600(c) of this chapter as follows: (1) No. 054771 for use of product described in paragraph (a)(1) as in paragraph (c) of this section. (2) Nos. 000061, 043264, and 059399 for use of product described in paragraph (a)(2) as in paragraph (c) of this section. Conditions of use in dogs and catsAmount.(c) —(1) Apply a thin film over the cornea 3 or 4 times daily. Indications for use.(2) Treatment of superficial bacterial infections of the eyelid and conjunctiva of dogs and cats when due to susceptible organisms. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37333, Aug. 18, 1992, as amended at 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, Feb. 27, 2014; 80 FR 61297, Oct. 13, 2015]

Specifications.(a) Each gram of ointment contains 400 units of bacitracin zinc, 5 milligrams (mg) of neomycin sulfate (equivalent to 3.5 mg of neomycin sulfate), 10,000 units of polymyxin B sulfate, and10 mg of hydrocortisone. Sponsors.(b) See Nos. 000061 and 043264 in § 510.600(c) of this chapter. Conditions of use in dogs and catsAmount.(c) —(1) Apply a thin film over the cornea three or four times daily. Indications for use.(2) For treating acute or chronic conjunctivitis caused by susceptible organisms. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37333, Aug. 18, 1992, as amended at 61 FR 8873, Mar. 6, 1996; 62 FR 61626, Nov. 19, 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, Feb. 27, 2014]

Specifications.(a) Each milliliter (mL) of solution contains 20 milligrams (mg) buprenorphine. The drug is supplied in tubes containing 0.4 mL (8 mg) or 1.0 mL (20 mg). Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter. Conditions of use in catsAmount.(c) —(1) Administer topically to the dorsal cervical area at the base of the skull a single dose of 1.2 to 3.1 mg/lb (2.7 to 6.7 mg/kg) approximately 1 to 2 hours before surgery. Indications for use.(2) For the control of postoperative pain associated with surgical procedures in cats. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Buprenorphine is a Schedule III controlled substance. [87 FR 58962, Sept. 29, 2022]

Specifications.(a) Each gram contains 10 milligrams chloramphenicol. Sponsors.(b) See Nos. 043264 and 054771 in § 510.600(c) of this chapter. Conditions of use in dogs and catsAmount.(c) —(1) Apply every 3 hours around the clock for 48 hours, after which night instillations may be omitted. Indications for use.(2) For treatment of bacterial conjunctivitis caused by pathogens susceptible to chloramphenicol. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the use of this drug in food-producing animals. [77 FR 4897, Feb. 1, 2012, as amended at 77 FR 64717, Oct. 23, 2012; 79 FR 10967, Feb. 27, 2014]

Specifications.(a) Each gram of ointment contains 10 milligrams chlorhexidine acetate. Sponsors.(b) See Nos. 054771 and 058829 in § 510.600(c) of this chapter. Conditions of use in dogs, cats, and horsesIndications for use.(c) —(1) For use as a topical antiseptic ointment for surface wounds. Limitations.(2) Do not use in horses intended for human consumption. [72 FR 265, Jan. 4, 2007, as amended at 79 FR 10967, Feb. 27, 2014]

Specifications.(a) Each gram of cream contains 10 milligrams of clotrimazole. Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter. Conditions of useAmount.1/4(c) —(1) Apply -inch ribbon of cream per square inch of lesion once daily for 2 to 4 weeks. Indications of use.Microsporum canisTrichophyton mentagrophytes.(2) For the treatment of fungal infections of dogs and cats caused by and Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 48128, July 18, 1980, as amended at 79 FR 10967, Feb. 27, 2014; 86 FR 14820, Mar. 19, 2021]

Amount.(a) The drug is a 37.5 percent solution of copper naphthenate. Sponsors.(b) See Nos. 017135, 054771, and 058829 in § 510.600(c) of this chapter. Conditions of use in horsesAmount.(c) —(1) Apply daily to affected hooves until fully healed. Indications for use.(2) As an aid in treating horses and ponies for thrush caused by organisms susceptible to copper naphthenate. Limitations.(3) Use on horses and ponies only. Avoid contact around eyes. Do not contaminate feed. Do not use in horses intended for human consumption. [47 FR 4250, Jan. 29, 1982, as amended at 68 FR 55825, Sept. 29, 2003; 71 FR 38074, July 5, 2006; 79 FR 10967, Feb. 27, 2014]

Specifications.(a) Each gram of ointment contains 2 milligrams of cyclosporine. Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter. Conditions of useAmount.1/4(c) —(1) Apply a -inch strip of ointment directly on the cornea or into the conjunctival sac of the affected eye(s) every 12 hours. Indications for use.(2) For management of chronic keratoconjunctivitis sicca (KCS) and chronic superficial keratitis (CSK) in dogs. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [60 FR 48651, Sept. 20, 1995, as amended at 62 FR 48940, Sept. 18, 1997; 79 FR 10967, Feb. 27, 2014]

Specifications.(a) Each gram of cream contains 10 milligrams diclofenac sodium. Sponsor.(b) See No. 000010 in § 510.600(c) of this chapter. Conditions of use in horsesAmount.(c) —(1) Apply a 5-inch (5″) ribbon of cream twice daily over the affected joint for up to 10 days and rub thoroughly into the hair covering the joint until it disappears. Indications for use in horses.(2) For the control of pain and inflammation associated with osteoarthritis in tarsal, carpal, metacarpophalangeal, metatarsophalangeal, and proximal interphalangeal (hock, knee, fetlock and pastern) joints. Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [69 FR 40767, July 7, 2004, as amended at 74 FR 26782, June 4, 2009; 74 FR 47436, Sept. 16, 2009]

Specifications.(a) (1) Each milliliter (mL) of solution contains 90 percent dimethyl sulfoxide and 10 percent water. (2) Each milliliter (mL) of gel product contains 90 percent dimethyl sulfoxide. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of use in horses and dogsAmountHorses.(c) —(1) —(i) Apply topically two to three times daily in an amount not to exceed 100 mL per day. Total duration of therapy should not exceed 30 days. Dogs.(ii) Apply topically three to four times daily in an amount not to exceed 20 mL per day. Total duration of therapy should not exceed 14 days. Indications for use.(2) To reduce acute swelling due to trauma. Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 10967, Feb. 27, 2014]

Specifications.(a) Each milliliter (mL) of solution contains 5 milligrams (mg) doramectin. Sponsors.(b) See Nos. 051072 and 054771 in § 510.600(c) of this chapter. Related tolerances.(c) See § 556.222 of this chapter. Special considerations.(d) See § 500.25 of this chapter. Conditions of use in cattleAmount.(e) —(1) Administer topically 1 mL (5 mg doramectin) per 22 lb (10 kg) of body weight. Indications for use.Ostertagia ostertagiOstertagia ostertagiOstertagia lyrataHaemonchus placeiTrichostrongylus axeiTrichostrongylus colubriformisCooperia oncophoraCooperia punctataCooperia pectinataCooperia surnabadaBunostomum phlebotomumOesophagostomum radiatumTrichuris spp.Dictyocaulus viviparusThelazia gulosaThelazia skrjabiniHypoderma bovisHypoderma lineatumLinognathus vituliHaematopinus eurysternusSolenopotes capillatusBovicola (Damalinia) bovisChorioptes bovisSarcoptes scabieiHaematobia irritansCooperia oncophoraDictyocaulus viviparusOstertagia ostertagiOesophagostomum radiatumCooperia punctataHaemonchus placeiLinognathus vituliBovicola (Damalinia) bovis(2) For treatment and control of gastrointestinal roundworms: (adults and fourth-stage larvae), (inhibited fourth-stage larvae),…

Specifications.(a) Each milliliter of solution contains 21.4 milligrams (mg) emodepside and 85.7 mg praziquantel. Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter. Conditions of use in catsAmount.(c) —(1) The recommended minimum dose is 1.36 mg/pound (lb) (3 mg/kilogram (kg)) emodepside and 5.45 mg/lb (12 mg/kg) praziquantel applied as a single topical dose. Indications for use.Ancylostoma tubaeformeToxocara catiDipylidium caninumTaenia taeniaeformis(2) For the treatment and control of hookworm infections caused by (adults, immature adults, and fourth stage larvae), roundworm infections caused by (adults and fourth stage larvae), and tapeworm infections caused by (adults) and (adults). Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [72 FR 42291, Aug. 2, 2007, as amended at 86 FR 14820, Mar. 19, 2021]

Specifications.(a) Each milliliter contains 5 milligrams (mg) enrofloxacin and 10 mg silver sulfadiazine. Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter. Conditions of useDogsAmount.(c) ——(1) 5 to 10 drops for dogs weighing 35 pounds (lb) or less and 10 to 15 drops for dogs weighing more than 35 lb; applied twice daily for up to 14 days. Indications for use.(2) For the treatment of otitis externa in dogs. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals. [65 FR 66620, Nov. 7, 2000, as amended at 79 FR 10967, Feb. 27, 2014; 86 FR 14821, Mar. 19, 2021]

Specifications.(a) Each milliliter (mL) contains 5 milligrams (mg) of eprinomectin. Sponsors.(b) See Nos. 000010, 051072, and 055529 in § 510.600(c) of this chapter. Related tolerances.(c) See § 556.227 of this chapter. Special considerations.(d) See § 500.25 of this chapter. Conditions of use in cattleAmount.(e) —(1) Apply 5 mg (1 mL) per 10 kilograms (kg) of body weight (500 micrograms/kg) topically along backbone from withers to tailhead. Indications for use.Haemonchus placeiOstertagia ostertagiTrichostrongylus axeiT. colubriformisT. longispicularisCooperia oncophoraC. punctataC. surnabadaNematodirus helvetianusBunostomum phlebotomumOesophagostomum radiatumStrongyloides papillosusTrichurisDictyocaulus viviparus,Hypoderma lineatum, H. bovisDamalinia bovis, Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatusChorioptes bovis, Sarcoptes scabieiHaematobia irritansD. viviparusH. irritans(2) For treatment and control of gastrointestinal roundworms ( (adult and L4), (adult and L4, including inhibited L4), (adult and L4), (adult and L4), (adult), (adult and L4), (adult and L4), (adult and L4), (adult and L4), (adult and L4), (adult and L4), (adults), spp.…

Specifications.(a) Each milliliter (mL) of solution contains 4 milligrams (mg) eprinomectin and 83 mg praziquantel. Sponsor.(b) See No. 000010 in § 510.600(c) of this chapter. Conditions of use in catsAmount.(c) —(1) Using the 0.3 mL and 0.9 mL unit applicators, administer a minimum dose of 0.23 mg eprinomectin per pound body weight and 4.55 mg praziquantel per pound body weight by topical application on the dorsal midline between the base of the skull and the shoulder blades. Indications for use.Dirofilaria immitis,Toxocara catiAncylostoma tubaeforme;Ancylostoma brazilienseDipylidium caninumEchinococcus multilocularis(2) For the prevention of heartworm disease caused by and for the treatment and control of roundworms (adult and fourth stage larval ), hookworms (adult and fourth stage larval adult ), and tapeworms (adult and ), in cats and kittens 7 weeks of age and older and 1.8 lbs or greater. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [83 FR 48946, Sept. 28, 2018, as amended at 84 FR 39184, Aug. 9, 2019]

Specifications.(a) Amitraz liquid contains 19.9 percent amitraz in an organic solvent. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of useIndications for use.Demodex canis(c) —(1) For dogs for the treatment of generalized demodicosis (). Amount.(2) One 10.6 milliliter bottle per 2 gallons of warm water (250 parts per million) for each treatment, for a total of 3 to 6 treatments, 14 days apart. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [47 FR 18589, Apr. 30, 1982, as amended at 79 FR 10967, Feb. 27, 2014]

Specifications.(a) The drug is in liquid form containing 13.2 percent famphur. Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter. Special considerations.(c) Do not use on animals simultaneously or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals. Related tolerances.(d) See § 556.273 of this chapter. Conditions of useAmount.(e) —(1) Apply 1 ounce per 200 pounds body weight, not to exceed a total dosage of 4 ounces, from the shoulder to the tail head as a single treatment. Apply as soon as possible after heel fly activity ceases. Indications for use in beef and nonlactating dairy cattle.(2) For control of cattle grubs and to reduce cattle lice infestations. Limitations.(3) Do not slaughter within 35 days after treatment. Do not use on lactating dairy cows or dry dairy cows within 21 days of freshening, calves less than 3 months old, animals stressed from castration, overexcitement or dehorning, sick or convalescent animals. Animals may become dehydrated and under stress following shipment. Do not treat until they are in good condition. Brahman and Brahman crossbreeds are less tolerant of…

Specifications.(a) (1) The drug is a liquid containing: (i) 3 percent of fenthion; or (ii) 20 percent fenthion. (2) The drug is a solution containing either 5.6 or 13.8 percent fenthion. Each concentration is available in 2 volumes which are contained in single-dose applicators. Sponsor.(b) See sponsors in § 510.600(c) of this chapter: (1) No. 058198 for use of product described in paragraph (a)(1)(i) of this section as in paragraph (d)(1) of this section. (2) No. 058198 for use of product described in paragraph (a)(1)(ii) of this section as in paragraph (d)(2) of this section. (3) No. 058198 for use of products described in paragraph (a)(2) of this section as in paragraph (d)(3) of this section. Related tolerances.(c) See § 556.280 of this chapter. Conditions of useBeef cattle and nonlactating dairy cattleAmount.(d) —(1) —(i) It is used at the rate of one-half fluid ounce per 100 pounds of body weight applied topically on the backline of the animal. Only one application per season should be made for grub control and this will also provide initial control of lice. A second application for lice control may be made if animals become reinfested, but no sooner than 35 days…

Specifications.(a) Each milliliter of gel contains 10 milligrams (mg) florfenicol, 10 mg terbinafine, and 1 mg betamethasone acetate. Sponsor.(b) See No. 043264 in § 510.600(c) of this chapter. Conditions of use in dogsAmount.(c) —(1) Administer one dose (1 tube) per affected ear(s) and repeat administration in 7 days. Indications for use.Staphylococcus pseudintermediusMalassezia pachydermatis(2) For the treatment of otitis externa in dogs associated with susceptible strains of bacteria () and yeast (). Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [80 FR 13230, Mar. 13, 2015, as amended at 86 FR 14821, Mar. 19, 2021]

Specifications.(a) Each single-dose, prefilled dropperette contains 1 milliliter (mL) of a solution containing 16.6 milligrams (mg) florfenicol, 14.8 mg terbinafine (equivalent to 16.6 mg terbinafine hydrochloride), and 2.2 mg mometasone furoate. Sponsor.(b) See Nos. 017030 and 058198 in § 510.600(c) of this chapter. Conditions of use in dogsAmount.(c) —(1) Administer one dropperette (1 mL) per affected ear(s). Indications for use.Malassezia pachydermatisStaphylococcus pseudintermedius(2) For the treatment of otitis externa in dogs associated with susceptible strains of yeast () and bacteria (). Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [80 FR 76387, Dec. 9, 2015, as amended at 83 FR 64740, Dec. 18, 2018; 86 FR 14821, Mar. 19, 2021; 88 FR 14901, Mar. 10, 2023]

Specifications.(a) Each milliliter of ophthalmic preparation contains 0.10 milligram flumethasone, 5.0 milligrams neomycin sulfate (3.5 milligrams neomycin base), and 10,000 units of polymyxin B sulfate, with or without hydroxypropyl methylcellulose. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of useAmountPreparation containing hydroxypropyl methylcellulose.(c) —(1) —(i) Dogs: 1 to 2 drops per eye, every 6 hours. Preparation without hydroxyproply methylcellulose.(ii) Dogs and cats: 2 to 3 drops per eye, every 4 hours. Indications for use.(2) Treatment of the inflammation, edema, and secondary bacterial infections associated with topical ophthalmological conditions of the eye such as corneal injuries, incipient pannus, superficial keratitis, conjunctivitis, acute nongranulomatous anterior uveitis, kerato- conjunctivitis, and blepharitis. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [44 FR 16012, Mar. 16, 1979, as amended at 61 FR 5507, Feb. 13, 1996; 79 FR 10968, Feb. 27, 2013]

Specifications.(a) Each milliliter of solution contains 50 milligrams (mg) flunixin (equivalent to 83 mg flunixin meglumine). Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter. Related tolerances.(c) See § 556.286 of this chapter. Conditions of useAmount.(d) —(1) Apply only once at a dose of 3.3 mg flunixin per kg body weight (1.5 mg/lb; 3 mL per 100 lbs) topically in a narrow strip along the dorsal midline from the withers to the tailhead. Indications for use.(2) For the control of pyrexia associated with bovine respiratory disease and acute bovine mastitis, and the control of pain associated with foot rot in beef cattle 2 months of age and older and dairy cattle. Limitations.(3) Not for use in beef and dairy bulls intended for breeding over 1 year of age. Milk that has been taken during treatment and for 48 hours after treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 8 days of treatment. Not for use in replacement dairy heifers 20 months of age or older or dry dairy cows; use in these cattle may cause drug residues in calves born to these cows or heifers. Not for use in beef calves less than 2 months of…