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§ 522.2690 21 CFR Ch. I (4–1–20 Edition)

(3) Steers fed in confinement for slaugh- PART 524—OPHTHALMIC AND TOP- ter—(i) Amount. 72 mg zeranol (one im- ICAL DOSAGE FORM NEW ANI- plant consisting of 6 pellets, each pel- MAL DRUGS let containing 12 mg zeranol) per im- plant dose. Sec. (ii) Indications for use. For increased 524.86 Amitraz. rate of weight gain and improved feed 524.154 Bacitracin, neomycin, and poly- efficiency. myxin B ophthalmic ointment. (iii) Limitations. Implant 524.155 Bacitracin, neomycin, polymyxin B, subcutaneously in ear only. Safety and and ophthalmic oint- ment. effectiveness have not been established 524.390 Chloramphenicol ophthalmic oint- in veal calves. A withdrawal period has ment. not been established for this product in 524.402 Chlorhexidine. preruminating calves. Do not use in 524.450 . calves to be processed for veal. 524.463 Copper naphthenate. (4) Pasture cattle (slaughter, stocker, 524.575 Cyclosporine ophthalmic ointment. feeder steers, and heifers)—(i) Amount. 524.590 . 524.660 Dimethyl sulfoxide. 138 mg zeranol (one implant consisting 524.770 . of 7 pellets, each of 6 pellets containing 524.775 Emodepside and . 20 mg zeranol and a seventh pellet con- 524.802 Enrofloxacin and silver sulfadiazine taining 18 mg zeranol) per implant otic emulsion. dose. 524.814 . (ii) Indications for use. For increased 524.815 Eprinomectin and praziquantel. rate of weight gain. 524.900 Famphur. 524.920 Fenthion. (iii) Limitations. Implant 524.955 Florfenicol, , and subcutaneously in ear only. Safety and otic gel. effectiveness have not been established 524.957 Florfenicol, terbinafine, and in veal calves. A withdrawal period has otic solution. not been established for this product in 524.960 Flumethasone, neomycin, and poly- preruminating calves. Do not use in myxin B ophthalmic solution. 524.970 . calves to be processed for veal. TOPICAL AND OTIC DOSAGE [59 FR 19639, Apr. 25, 1994; 60 FR 26360, May FORMS 17, 1995, as amended at 62 FR 61625, Nov. 19, 1997; 64 FR 46840, Aug. 27, 1999; 67 FR 6867, 524.981 [Reserved] Feb. 14, 2002; 70 FR 6764, Feb. 9, 2005] 524.981a Fluocinolone cream. 524.981b Fluocinolone solution. § 522.2690 Zinc gluconate. 524.981c Fluocinolone and neomycin cream. 524.981d Fluocinolone and dimethyl sulf- (a) Specifications. Each milliliter of oxide solution. solution contains 13.1 milligrams zinc 524.981e Fluocinolone and dimethyl sulf- as zinc gluconate neutralized to pH 7.0 oxide otic solution. with L-arginine. 524.998 Fluralaner. (b) Sponsor. See No. 076175 in 524.1001 Furalaner and . § 510.600(c) of this chapter. 524.1005 Furazolidone powder. 524.1044 Gentamicin sophthalmic and top- (c) Conditions of use in —(1) ical dosage forms. Amount. The volume injected into each 524.1044a Gentamicin ophthalmic solution. testicle is based on testicular width as 524.1044b Gentamicin and betamethasone determined by measuring each testicle otic solution. at its widest point using a metric scale 524.1044c Gentamicin ophthalmic ointment. (millimeter) caliper. 524.1044d Gentamicin and betamethasone ointment. (2) Indications for use. Intratesticular 524.1044e Gentamicin spray. injection for chemical sterilization of 524.1044f Gentamicinand betamethasone 3- to 10-month-old male dogs. spray. (3) Limitations. Federal law restricts 524.1044g Gentamicin, betamethasone, and this drug to use by or on the order of a clotrimazole ointment. licensed veterinarian. 524.1044h Gentamicin, mometasone, and clotrimazole otic suspension. [68 FR 26995, May 19, 2003, as amended at 76 524.1044i Gentamicin and betamethasone FR 79064, Dec. 21, 2011] ophthalmic solution.

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524.1132 Hydrocortisone, , and 524.2099 Selamectin and sarolaner. gentamicin otic suspension. 524.2101 disulfide suspension. 524.1140 and . 524.2350 cream. 524.1146 Imidacloprid and moxidectin. 524.2482 spray. 524.1193 Ivermectin topical solution. 524.2483 Triamcinolone cream. 524.1195 Ivermectin otic suspension. 524.2620 Liquid crystalline trypsin, Peru 524.1200 Kanamycin ophthalmic and topical balsam, castor oil. dosage forms. 524.1200a Kanamycin ophthalmic ointment. AUTHORITY: 21 U.S.C. 360b. 524.1200b Kanamycin ophthalmic solution. SOURCE: 40 FR 13873, Mar. 27, 1975, unless 524.1204 Kanamycin, amphomycin, and hy- otherwise noted. drocortisone ointment. 524.1240 . 524.1376 2-Mercaptobenzothiazole solution. § 524.86 Amitraz. 524.1443 Miconazole. (a) Specifications. Amitraz liquid con- 524.1445 Miconazole, polymixin B, and pred- tains 19.9 percent amitraz in an organic nisolone suspension. solvent. 524.1446 otic solution. 524.1448 Mirtazapine transdermal ointment. (b) Sponsor. See No. 054771 in 524.1450 Moxidectin. § 510.600(c) of this chapter. 524.1465 Mupirocin. (c) Conditions of use—(1) Indications 524.1484 Neomycin ophthalmic and topical for use. For dogs for the treatment of dosage forms. generalized demodicosis (Demodex 524.1484b Neomycin, isoflupredone, tetra- canis). caine, and myristyl-gamma-picolinium (2) Amount. One 10.6 milliliter bottle powder. 524.1484c Neomycin, isoflupredone, and tet- per 2 gallons of warm water (250 parts racaine ointment. per million) for each treatment, for a 524.1484d Neomycin, hydrocortisone, and total of 3 to 6 treatments, 14 days tetracaine otic ointment. apart. 524.1484e Neomycin and polymyxin B oph- (3) Limitations. Federal law restricts thalmic solution. this drug to use by or on the order of a 524.1484f Neomycin, , and tetra- licensed veterinarian. caine otic suspension. 524.1484g Neomycin, thiabendazole, and [47 FR 18589, Apr. 30, 1982, as amended at 79 solution. FR 10967, Feb. 27, 2014] 524.1484h Neomycin, penicillin, polymyxin B, and hydrocortisone suspension. § 524.154 Bacitracin, neomycin, and 524.1484i Neomycin and hydrocortisone oint- polymyxin B ophthalmic ointment. ment. 524.1484j Neomycin and prednisolone oph- (a) Specifications. Each gram of oint- thalmic ointment. ment contains: 524.1484k Neomycin and prednisolone sus- (1) 500 units bacitracin, 3.5 milli- pension. grams (mg) neomycin sulfate (equiva- 524.1580 Nitrofurazone topical dosage forms. lent to 3.5 mg neomycin base), and 524.1580a Nitrofurazone ointment. 10,000 units polymyxin B sulfate; or 524.1580b Nitrofurazone soluble powder. 524.1580c Nitrofurazone and butacaine oint- (2) 400 units bacitracin zinc, 5 mg ne- ment. omycin sulfate (equivalent to 3.5 mg 524.1600 ophthalmic and topical neomycin base), and 10,000 units poly- dosage forms. myxin B sulfate. 524.1600a Nystatin, neomycin, thiostrepton, (b) Sponsors. See sponsor numbers in and triamcinolone ointment. § 510.600(c) of this chapter as follows: 524.1600b Nystatin, neomycin, thiostrepton, (1) No. 054771 for use of product de- and triamcinolone ophthalmic ointment 524.1610 Orbifloxacin, mometasone furoate scribed in paragraph (a)(1) as in para- monohydrate, and suspen- graph (c) of this section. sion. (2) Nos. 000061, 043264, and 059399 for 524.1662 Oxytetracycline ophthalmic and use of product described in paragraph topical dosage forms. (a)(2) as in paragraph (c) of this sec- 524.1662a Oxytetracycline and hydro- tion. spray. (c) Conditions of use in dogs and cats— 524.1662b Oxytetracycline and polymyxin B ophthalmic ointment. (1) Amount. Apply a thin film over the 524.1742 Phosmet emulsifiable liquid. cornea 3 or 4 times daily. 524.1982 Proparacaine ophthalmic solution. (2) Indications for use. Treatment of 524.2098 Selamectin. superficial bacterial of the

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eyelid and conjunctiva of dogs and cats § 524.402 Chlorhexidine. when due to susceptible organisms. (a) Specifications. Each gram of oint- (3) Limitations. Federal law restricts ment contains 10 milligrams this drug to use by or on the order of a chlorhexidine acetate. licensed veterinarian. (b) Sponsors. See Nos. 054771 and [57 FR 37333, Aug. 18, 1992, as amended at 61 058829 in § 510.600(c) of this chapter. FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, (c) Conditions of use in dogs, cats, and 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, horses—(1) Indications for use. For use Feb. 27, 2014; 80 FR 61297, Oct. 13, 2015] as a topical antiseptic ointment for § 524.155 Bacitracin, neomycin, poly- surface wounds. myxin B, and hydrocortisone oph- (2) Limitations. Do not use in horses thalmic ointment. intended for human consumption. (a) Specifications. Each gram of oint- [72 FR 265, Jan. 4, 2007, as amended at 79 FR ment contains 400 units of bacitracin 10967, Feb. 27, 2014] zinc, 5 milligrams (mg) of neomycin sulfate (equivalent to 3.5 mg of neomy- § 524.450 Clotrimazole. cin sulfate), 10,000 units of polymyxin B (a) Specifications. Each gram of cream sulfate, and10 mg of hydrocortisone. contains 10 milligrams of clotrimazole. (b) Sponsors. See Nos. 000061 and (b) Sponsors. See No. 000859 in 043264 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— (c) Conditions of use—(1) Amount. (1) Amount. Apply a thin film over the Apply 1⁄4-inch ribbon of cream per cornea three or four times daily. square inch of lesion once daily for 2 to (2) Indications for use. For treating 4 weeks. acute or chronic conjunctivitis caused (2) Indications of use. For the treat- by susceptible organisms. ment of fungal infections of dogs and (3) Limitations. Federal law restricts cats caused by Microsporum canis and this drug to use by or on the order of a Trichophyton mentagrophytes. licensed veterinarian. (3) Limitations. Federal law restricts [57 FR 37333, Aug. 18, 1992, as amended at 61 this drug to use by or on the order of a FR 8873, Mar. 6, 1996; 62 FR 61626, Nov. 19, licensed veterinarian. 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, [40 FR 48128, July 18, 1980, as amended at 79 Feb. 27, 2014] FR 10967, Feb. 27, 2014] § 524.390 Chloramphenicol ophthalmic § 524.463 Copper naphthenate. ointment. (a) Amount. The drug is a 37.5 percent (a) Specifications. Each gram contains solution of copper naphthenate. 10 milligrams chloramphenicol. (b) Sponsors. See Nos. 017135, 054771, (b) Sponsors. See Nos. 043264 and and 058829 in § 510.600(c) of this chapter. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) (c) Conditions of use in dogs and cats— (1) Amount. Apply every 3 hours around Amount. Apply daily to affected hooves the clock for 48 hours, after which until fully healed. night instillations may be omitted. (2) Indications for use. As an aid in (2) Indications for use. For treatment treating horses and ponies for thrush of bacterial conjunctivitis caused by caused by organisms susceptible to pathogens susceptible to chloramphen- copper naphthenate. icol. (3) Limitations. Use on horses and (3) Limitations. Federal law restricts ponies only. Avoid contact around this drug to use by or on the order of a eyes. Do not contaminate feed. Do not licensed veterinarian. Federal law pro- use in horses intended for human con- hibits the use of this drug in food-pro- sumption. ducing animals. [47 FR 4250, Jan. 29, 1982, as amended at 68 [77 FR 4897, Feb. 1, 2012, as amended at 77 FR FR 55825, Sept. 29, 2003; 71 FR 38074, July 5, 64717, Oct. 23, 2012; 79 FR 10967, Feb. 27, 2014] 2006; 79 FR 10967, Feb. 27, 2014]

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§ 524.575 Cyclosporine ophthalmic (b) Sponsor. See No. 054771 in ointment. § 510.600(c) of this chapter. (a) Specifications. Each gram of oint- (c) Conditions of use in horses and —(1) —(i) Apply ment contains 2 milligrams of dogs Amount Horses. topically two to three times daily in an cyclosporine. amount not to exceed 100 mL per day. (b) Sponsor. See No. 000061 in Total duration of therapy should not § 510.600(c) of this chapter. exceed 30 days. (c) Conditions of use—(1) Amount. (ii) Dogs. Apply topically three to 1 Apply a ⁄4-inch strip of ointment di- four times daily in an amount not to rectly on the cornea or into the con- exceed 20 mL per day. Total duration of junctival sac of the affected eye(s) therapy should not exceed 14 days. every 12 hours. (2) Indications for use. To reduce acute (2) Indications for use. For manage- swelling due to trauma. ment of chronic keratoconjunctivitis (3) Limitations. Do not use in horses sicca (KCS) and chronic superficial intended for human consumption. Fed- keratitis (CSK) in dogs. eral law restricts this drug to use by or (3) Limitations. Federal law restricts on the order of a licensed veterinarian. this drug to use by or on the order of a licensed veterinarian. [79 FR 10967, Feb. 27, 2014] [60 FR 48651, Sept. 20, 1995, as amended at 62 § 524.770 Doramectin. FR 48940, Sept. 18, 1997; 79 FR 10967, Feb. 27, (a) Specifications. Each milliliter 2014] (mL) of solution contains 5 milligrams (mg) doramectin. § 524.590 Diclofenac. (b) Sponsor. See No. 054771 in (a) Specifications. Each gram of cream § 510.600(c) of this chapter. contains 10 milligrams diclofenac so- (c) Related tolerances. See § 556.222 of dium. this chapter. (b) Sponsor. See No. 000010 in (d) Special considerations. See § 500.25 § 510.600(c) of this chapter. of this chapter. (c) Conditions of use in horses—(1) (e) Conditions of use in cattle—(1) Amount. Apply a 5-inch (5″) ribbon of Amount. Administer topically as a sin- cream twice daily over the affected gle dose 0.5 mg (1 mL) per kilogram (1 joint for up to 10 days and rub thor- mL per 22 pounds) body weight. oughly into the hair covering the joint (2) Indications for use. For treatment until it disappears. and control of gastrointestinal (2) Indications for use in horses. For roundworms: Ostertagia ostertagi (adults the control of pain and inflammation and fourth-stage larvae), Ostertagia associated with osteoarthritis in tar- ostertagi (inhibited fourth-stage lar- sal, carpal, metacarpophalangeal, vae), Ostertagia lyrata (adults), metatarsophalangeal, and proximal Haemonchus placei (adults and fourth- interphalangeal (hock, knee, fetlock stage larvae), Trichostrongylus axei and pastern) joints. (adults and fourth-stage larvae), Trichostrongylus colubriformis (adults (3) Limitations. Do not use in horses and fourth-stage larvae), intended for human consumption. Fed- Cooperia (adults and fourth-stage lar- eral law restricts this drug to use by or oncophora vae), (adults and on the order of a licensed veterinarian. Cooperia punctata fourth-stage larvae), Cooperia pectinata [69 FR 40767, July 7, 2004, as amended at 74 (adults), Cooperia surnabada (adults), FR 26782, June 4, 2009; 74 FR 47436, Sept. 16, Bunostomum phlebotomum (adults), 2009] Oesophagostomum radiatum (adults and fourth-stage larvae), Trichuris spp. § 524.660 Dimethyl sulfoxide. (adults); lungworms: Dictyocaulus (a) Specifications—(1) Each milliliter viviparus (adults and fourth-stage lar- (mL) of solution contains 90 percent di- vae); eyeworms: Thelazia gulosa methyl sulfoxide and 10 percent water. (adults), Thelazia skrjabini (adults); (2) Each milliliter (mL) of gel prod- grubs: Hypoderma bovis and Hypoderma uct contains 90 percent dimethyl sulf- lineatum; sucking lice: Linognathus oxide. vituli, Haematopinus eurysternus, and

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Solenopotes capillatus; biting lice: § 524.802 Enrofloxacin and silver sulfa- Bovicola (Damalinia) bovis; mange diazine otic emulsion. mites: Chorioptes bovis and Sarcoptes (a) Specifications. Each milliliter con- scabiei; horn flies: Haematobia irritans; tains 5 milligrams (mg) enrofloxacin and to control infections and to protect and 10 mg silver sulfadiazine. from reinfection with Cooperia (b) Sponsor. See No. 000859 in oncophora, Dictyocaulus viviparus, § 510.600(c) of this chapter. Ostertagia ostertagi, and (c) Conditions of use—Dogs—(1) Oesophagostomum radiatum for 28 days; Amount. 5 to 10 drops for dogs weighing and with Cooperia punctata and 35 pounds (lb) or less and 10 to 15 drops Haemonchus placei for 35 days after for dogs weighing more than 35 lb; ap- treatment; and to control infestations plied twice daily for up to 14 days. and to protect from reinfestation with (2) Indications for use. For the treat- Linognathus vituli for 42 days and with ment of otitis externa in dogs. Bovicola (Damalinia) bovis for 77 days (3) Limitations. Federal law restricts after treatment. this drug to use by or on the order of a (3) Limitations. Do not slaughter cat- licensed veterinarian. Federal law pro- tle within 45 days of latest treatment. hibits the extralabel use of this drug in This product is not approved for use in food-producing animals. female dairy cattle 20 months of age or [65 FR 66620, Nov. 7, 2000, as amended at 79 older, including dry dairy cows. Use in FR 10967, Feb. 27, 2014] these cattle may cause drug residues in milk and/or in calves born to these § 524.814 Eprinomectin. cows. A withdrawal period has not been (a) Specifications. Each milliliter established for this product in (mL) contains 5 milligrams (mg) of preruminating calves. Do not use in eprinomectin. calves to be processed for veal. (b) Sponsors. See Nos. 000010 and [69 FR 48392, Aug. 10, 2004, as amended at 70 055529 in § 510.600(c) of this chapter. FR 43046, July 26, 2005; 79 FR 10967, Feb. 27, (c) Related tolerances. See § 556.227 of 2014; 84 FR 32993, July 11, 2019] this chapter. (d) Special considerations. See § 500.25 § 524.775 Emodepside and of this chapter. praziquantel. (e) Conditions of use in cattle—(1) (a) Specifications. Each milliliter of Amount. Apply 5 mg (1 mL) per 10 kilo- solution contains 21.4 milligrams (mg) grams (kg) of body weight (500 emodepside and 85.7 mg praziquantel. micrograms/kg) applied topically along (b) Sponsor. See No. 000859 in backbone from withers to tailhead. § 510.600(c) of this chapter. (2) Indications for use. For treatment (c) Conditions of use in cats—(1) and control of gastrointestinal Amount. The recommended minimum roundworms (Haemonchus placei (adult dose is 1.36 mg/pound (lb) (3 mg/kilo- and L4), Ostertagia ostertagi (adult and gram (kg)) emodepside and 5.45 mg/lb L4, including inhibited L4), (12 mg/kg) praziquantel applied as a Trichostrongylus axei (adult and L4), T. single topical dose. colubriformis (adult and L4), T. (2) Indications for use. For the treat- longispicularis (adult), Cooperia ment and control of hookworm infec- oncophora (adult and L4), C. punctata tions caused by (adult and L4), C. surnabada (adult and (adults, immature adults, and fourth L4), Nematodirus helvetianus (adult and stage larvae), roundworm infections L4), Bunostomum phlebotomum (adult caused by Toxocara cati (adults and and L4), Oesophagostomum radiatum fourth stage larvae), and tapeworm in- (adult and L4), Strongyloides papillosus fections caused by Dipylidium caninum (adults), Trichuris spp. (adults)); (adults) and Taenia taeniaeformis lungworms (Dictyocaulus viviparus, (adults). adult and L4); cattle grubs (all para- sitic stages Hypoderma lineatum, H. (3) Limitations. Federal law restricts bovis); lice (Damalinia bovis, this drug to use by or on the order of a Linognathus vituli, Haematopinus licensed veterinarian. eurysternus, Solenopotes capillatus); [72 FR 42291, Aug. 2, 2007] mange mites (Chorioptes bovis, Sarcoptes

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scabiei); and horn flies (Haematobia (d) Related tolerances. See § 556.273 of irritans). Controls and protects from re- this chapter. of D. viviparus for 21 days (e) Conditions of use—(1) Amount. after treatment and H. irritans for 7 Apply 1 ounce per 200 pounds body days after treatment. weight, not to exceed a total dosage of (3) Limitations. A withdrawal period 4 ounces, from the shoulder to the tail has not been established for head as a single treatment. Apply as preruminating calves. Do not use in soon as possible after heel fly activity calves to be processed for veal. ceases. (2) Indications for use in beef and non- [76 FR 72619, Nov. 25, 2011, as amended at 83 FR 48946, Sept. 28, 2018; 84 FR 39184, Aug. 9, lactating dairy cattle. For control of cat- 2019] tle grubs and to reduce cattle lice in- festations. § 524.815 Eprinomectin and (3) Limitations. Do not slaughter with- praziquantel. in 35 days after treatment. Do not use (a) Specifications. Each milliliter on lactating dairy cows or dry dairy (mL) of solution contains 4 milligrams cows within 21 days of freshening, (mg) eprinomectin and 83 mg calves less than 3 months old, animals praziquantel. stressed from castration, overexcite- (b) Sponsor. See No. 000010 in ment or dehorning, sick or convales- § 510.600(c) of this chapter. cent animals. Animals may become de- (c) Conditions of use in cats—(1) hydrated and under stress following Amount. Using the 0.3 mL and 0.9 mL shipment. Do not treat until they are unit applicators, administer a min- in good condition. Brahman and Brah- imum dose of 0.23 mg eprinomectin per man crossbreeds are less tolerant of pound body weight and 4.55 mg cholinesterase-inhibiting insecticides praziquantel per pound body weight by than other breeds. Do not treat Brah- topical application on the dorsal man bulls. Swine should be eliminated midline between the base of the skull from area where runoff occurs. and the shoulder blades. [40 FR 13873, Mar. 27, 1975, as amended at 49 (2) Indications for use. For the preven- FR 34352, Aug. 30, 1984; 57 FR 7652, Mar. 4, tion of heartworm disease caused by 1992; 59 FR 28769, June 3, 1994; 62 FR 55161, , and for the treat- Oct. 23, 1997; 62 FR 61626, Nov. 19, 1997; 69 FR ment and control of roundworms (adult 41427, July 9, 2004; 79 FR 10968, Feb. 27, 2014; 83 FR 48946, Sept. 28, 2018] and fourth stage larval Toxocara cati), hookworms (adult and fourth stage lar- § 524.920 Fenthion. val Ancylostoma tubaeforme; adult Ancylostoma braziliense), and tapeworms (a) Specifications. (1) The drug is a liq- (adult Dipylidium caninum and uid containing: Echinococcus multilocularis), in cats and (i) 3 percent of fenthion; or kittens 7 weeks of age and older and 1.8 (ii) 20 percent fenthion. lbs or greater. (2) The drug is a solution containing either 5.6 or 13.8 percent fenthion. Each (3) Limitations. Federal law restricts this drug to use by or on the order of a concentration is available in 2 volumes licensed veterinarian. which are contained in single-dose ap- plicators. [83 FR 48946, Sept. 28, 2018, as amended at 84 (b) Sponsor. See sponsors in FR 39184, Aug. 9, 2019] § 510.600(c) of this chapter: (1) No. 000859 for use of product de- § 524.900 Famphur. scribed in paragraph (a)(1)(i) as in para- (a) Specifications. The drug is in liquid graph (d)(1) of this section. form containing 13.2 percent famphur. (2) No. 000859 for use of product de- (b) Sponsor. See No. 000061 in scribed in paragraph (a)(1)(ii) as in § 510.600(c) of this chapter. paragraph (d)(2) of this section. (c) Special considerations. Do not use (3) No. 000859 for use of products de- on animals simultaneously or within a scribed in paragraph (a)(2) as in para- few days before or after treatment with graph (d)(3) of this section. or exposure to cholinesterase-inhib- (c) Related tolerances. See § 556.280 of iting drugs, pesticides, or chemicals. this chapter.

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(d) Conditions of use—(1) Beef cattle sooner than 35 days after the first and nonlactating dairy cattle—(i) treatment. Amount. It is used at the rate of one- (ii) Indications for use. For control of half fluid ounce per 100 pounds of body cattle grubs and as an aid in control- weight applied topically on the ling lice on beef cattle and on dairy backline of the animal. Only one appli- cattle not of breeding age. cation per season should be made for (iii) Limitations. Do not use on ani- grub control and this will also provide mals simultaneously or within a few initial control of lice. A second appli- days before or after treatment with or cation for lice control may be made if exposure to cholinesterase-inhibiting animals become reinfested, but no drugs, pesticides, or chemicals. Host- sooner than 35 days after the first parasite reactions such as bloat, saliva- treatment. Proper timing of treatment tion, staggering and paralysis may is important for grub control; cattle sometimes occur when cattle are treat- should be treated as soon as possible ed while the common cattle grub after heel-fly activity ceases. (Hypoderma lineatum) is in the gullet, (ii) Indications for use. For the control or while the northern cattle grub (H. of grubs and lice in beef and nonlac- bovis) is in the area of the spinal cord. tating cattle. Cattle should be treated before these (iii) Limitations. Do not use on ani- stages of grub development. Consult mals simultaneously or within a few your veterinarian, extension livestock days before or after treatment with or specialist, or extension entomologist exposure to cholinesterase-inhibiting regarding the timing of treatment. If it drugs, pesticides, or chemicals. Cattle is impossible to determine the area should not be slaughtered within 35 from which the cattle came and/or days following a single treatment. If a exact stage of the grubs, it is rec- second application is made for lice con- ommended that the cattle receive only trol, cattle should not be slaughtered a maintenance ration of low-energy within 45 days of the second treatment. feed during the treatment period. This The drug must not be used within 28 lessens the likelihood of severe bloat days of freshening of dairy cattle. If which may occur in cattle on full feed freshening should occur within 28 days when the common grub is killed while after treatment, do not use milk as in the gullet. Do not treat dairy cattle human food for the balance of the 28- of breeding age; calves less than 3 day interval. Do not treat lactating months old; sick, convalescent, or se- dairy cattle; calves less than 3 months verely stressed livestock. Do not treat old; or sick, convalescent, or stressed cattle for 10 days before or after ship- livestock. Do not treat cattle for 10 ping, weaning, dehorning, or after ex- days before or after shipping, weaning, posure to contagious or infectious dis- or dehorning or after exposure to con- eases. Do not slaughter within 45 days tagious infectious diseases. of treatment. (2) Beef cattle and dairy cattle not of (3) Dogs—(i) Amount. Four to 8 milli- breeding age—(i) Amount. It is adminis- grams per kilogram of body weight. tered as a single, topical application Apply the contents of the proper size, placed on the backline of animals as single-dose tube directly to one spot on follows: For animals weighing 150 to the ’s skin. 300 pounds, apply 4 milliliters (mL); for (ii) Indications for use. For flea con- animals weighing 301 to 600 pounds, trol on dogs only. apply 8 mL; for animals weighing 601 to (iii) Limitations. Federal law restricts 900 pounds, apply 12 mL; for animals this drug to use by or on the order of a weighing 901 to 1,200 pounds, apply 16 licensed veterinarian. mL; and for animal weighing over 1,200 pounds, apply 20 mL. For most effec- [79 FR 10968, Feb. 27, 2014, as amended at 84 tive results, cattle should be treated as FR 32993, July 11, 2019] soon as possible after heel-fly activity ceases. A second application is required § 524.955 Florfenicol, terbinafine, and for animals heavily infested with lice otic gel. or for those which become reinfested. A (a) Specifications. Each milliliter of second application should be made no gel contains 10 milligrams (mg)

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florfenicol, 10 mg terbinafine, and 1 mg (ii) Preparation without hydroxyproply betamethasone acetate. methylcellulose. Dogs and cats: 2 to 3 (b) Sponsor. See No. 058198 in drops per eye, every 4 hours. § 510.600(c) of this chapter. (2) Indications for use. Treatment of (c) Conditions of use in dogs—(1) the inflammation, edema, and sec- Amount. Administer one dose (1 tube) ondary bacterial infections associated per affected ear(s) and repeat adminis- with topical ophthalmological condi- tration in 7 days. tions of the eye such as corneal inju- (2) Indications for use. For the treat- ries, incipient pannus, superficial kera- ment of otitis externa in dogs associ- titis, conjunctivitis, acute ated with susceptible strains of bac- nongranulomatous anterior uveitis, teria (Staphylococcus pseudintermedius) kerato- conjunctivitis, and blepharitis. and yeast ( pachydermatis). (3) Limitations. Federal law restricts (3) Limitations. Federal law restricts this drug to use by or on the order of a this drug to use by or on the order of a licensed veterinarian. licensed veterinarian. [80 FR 13230, Mar. 13, 2015] [44 FR 16012, Mar. 16, 1979, as amended at 61 FR 5507, Feb. 13, 1996; 79 FR 10968, Feb. 27, § 524.957 Florfenicol, terbinafine, and 2013] mometasone otic solution. § 524.970 Flunixin. (a) Specifications. Each single-dose, prefilled dropperette contains 1 milli- (a) Specifications. Each milliliter of liter (mL) of a solution containing 16.6 solution contains 50 milligrams (mg) milligrams (mg) florfenicol, 14.8 mg flunixin (equivalent to 83 mg flunixin terbinafine (equivalent to 16.6 mg meglumine). terbinafine hydrochloride), and 2.2 mg (b) Sponsor. See No. 000061 in mometasone furoate. § 510.600(c) of this chapter. (b) Sponsor. See No. 000859 in (c) Related tolerances. See § 556.286 of § 510.600(c) of this chapter. this chapter. (c) Conditions of use in dogs—(1) (d) Conditions of use—(1) Amount. Amount. Administer one dropperette (1 Apply only once at a dose of 3.3 mg mL) per affected ear(s). flunixin per kg body weight (1.5 mg/lb; (2) Indications for use. For the treat- 3 mL per 100 lbs) topically in a narrow ment of otitis externa in dogs associ- strip along the dorsal midline from the ated with susceptible strains of yeast withers to the tailhead. (Malassezia pachydermatis) and bacteria (2) Indications for use. For the control (Staphylococcus pseudintermedius). of pyrexia associated with bovine res- (3) Limitations. Federal law restricts piratory disease and the control of pain this drug to use by or on the order of a associated with foot rot in steers, beef licensed veterinarian. heifers, beef cows, beef bulls intended [80 FR 76387, Dec. 9, 2015, as amended at 83 for slaughter, and replacement dairy FR 64740, Dec. 18, 2018] heifers under 20 months of age. (3) Limitations. Federal law restricts § 524.960 Flumethasone, neomycin, and polymyxin B ophthalmic solu- this drug to use by or on the order of a tion. licensed veterinarian. Cattle must not be slaughtered for human consumption (a) Specifications. Each milliliter of within 8 days of the last treatment. ophthalmic preparation contains 0.10 Not for use in female dairy cattle 20 milligram flumethasone, 5.0 milligrams months of age or older, including dry neomycin sulfate (3.5 milligrams neo- dairy cows; use in these cattle may mycin base), and 10,000 units of poly- cause drug residues in milk and/or in myxin B sulfate, with or without calves born to these cows or heifers. hydroxypropyl methylcellulose. Not for use in suckling beef calves, (b) See No. 054771 in Sponsor. dairy calves, and veal calves. A with- § 510.600(c) of this chapter. drawal period has not been established (c) Conditions of use—(1) Amount—(i) for this product in pre-ruminating Preparation containing hydroxypropyl calves. methylcellulose. Dogs: 1 to 2 drops per eye, every 6 hours. [83 FR 13635, Mar. 30, 2018]

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FLUOCINOLONE TOPICAL AND OTIC and 0.5 percent neomycin sulfate (0.35 DOSAGE FORMS percent neomycin base). (b) Sponsor. See No. 099207 in § 524.981 [Reserved] § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) § 524.981a Fluocinolone cream. Amount—A small amount is applied to (a) Specifications. The drug contains the affected area two or three times 0.025 percent . daily. (b) Sponsor. See No. 099207 in (2) Indications for use—(i) Dogs. For § 510.600(c) of this chapter. the relief of pruritis and inflammation (c) Conditions of use in dogs—(1) associated with superficial acute and Amount—A small amount is applied to chronic dermatoses. It is used in the the affected area two or three times treatment of allergic and acute moist daily. dermatitis and nonspecific dermatoses. (2) Indications for use. For the relief of (ii) Dogs and cats. Used in the treat- pruritis and inflammation associated ment of wound infections. with certain superficial acute and (3) Federal law restricts this drug to chronic dermatoses. It is used in the use by or on the order of a licensed vet- treatment of allergic and acute moist erinarian. dermatitis and for the relief of super- [40 FR 13873, Mar. 27, 1975, as amended at 62 ficial inflammation caused by chemical FR 40932, July 31, 1997; 79 FR 10969, Feb. 27, burns and physical abrasions. 2014] (3) Federal law restricts this drug to use by or on the order of a licensed vet- § 524.981d Fluocinolone and dimethyl sulfoxide solution. erinarian. (a) Specifications. Each milliliter of [40 FR 13873, Mar. 27, 1975, as amended at 62 solution contains 0.01 percent FR 40932, July 31, 1997; 79 FR 10968, Feb. 27, fluocinolone acetonide and 20 percent 2014] dimethyl sulfoxide. § 524.981b Fluocinolone solution. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (a) Specifications. The drug contains (c) Conditions of use in dogs—(1) 0.01 percent fluocinolone acetonide. Amount—Instill 1 to 2 milliliters into (b) Sponsor. See No. 099207 in each anal sac following expression of § 510.600(c) of this chapter. anal sac contents. (c) Conditions of use in dogs—(1) (2) Indications for use. For the relief of Amount—A small amount of solution is impaction commonly present in appar- applied to the affected area two or ently normal anal sacs, for the reversal three times daily. of inflammatory changes associated (2) Indications for use—(i) Dogs. For with abnormal anal sacs, and to coun- the relief of pruritis and inflammation teract the offensive odor of anal sac se- associated with otitis externa and cer- cretions. tain superficial acute and chronic (3) Limitations. Federal law restricts dermatoses. this drug to use by or on the order of a (ii) Cats. For the relief of pruritis and licensed veterinarian. inflammation associated with acute [79 FR 10969, Feb. 27, 2014] otitis externa and certain superficial acute and chronic dermatoses. § 524.981e Fluocinolone and dimethyl (3) Federal law restricts this drug to sulfoxide otic solution. use by or on the order of a licensed vet- (a) Specifications. Each milliliter of erinarian. solution contains 0.01 percent [40 FR 13873, Mar. 27, 1975, as amended at 62 fluocinolone acetonide and 60 percent FR 40932, July 31, 1997; 79 FR 10969, Feb. 27, dimethyl sulfoxide. 2014] (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 524.981c Fluocinolone and neomycin (c) Conditions of use in dogs—(1) cream. Amount—Instill 4 to 6 drops (0.2 milli- (a) Specifications. The drug contains liter) twice daily into the ear canal for 0.025 percent fluocinolone acetonide a maximum period of 14 days. The total

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dosage used should not exceed 17 milli- tens 6 months of age and older, and liters. weighing 2.6 lb or greater. (2) Indications for use. For the relief of (iii) Limitations. Federal law restricts pruritis and inflammation associated this drug to use by or on the order of a with acute and chronic otitis. licensed veterinarian. (3) Limitations. Federal law restricts this drug to use by or on the order of a [81 FR 67152, Sept. 30, 2016, as amended at 82 licensed veterinarian. FR 43485, Sept. 18, 2017] [79 FR 10969, Feb. 27, 2014] § 524.1001 Furalaner and moxidectin. § 524.998 Fluralaner. (a) Specifications. Each milliliter of solution contains 280 milligram (mg) (a) Specifications. Each milliliter of solution contains 280 milligrams (mg) furalaner and 14 mg moxidectin. Each fluralaner. individually packaged tube contains ei- (b) Sponsor. See No. 000061 in ther 112.5 mg furalaner and 5.6 mg § 510.600(c) of this chapter. moxidectin; 250 mg furalaner and 12.5 (c) Conditions of use—(1) Dogs—(i) mg moxidectin; or 500 mg furalaner and Amount. Administer topically as a sin- 25 mg moxidectin. gle dose every 12 weeks according to (b) Sponsor. See No. 000061 in the label dosage schedule to provide a § 510.600(c) of this chapter. minimum dose of 11.4 mg/lb (25 mg/kg) (c) Conditions of use—(1) Amount. Ad- body weight. May be administered minister topically as a single dose every 8 weeks in case of potential expo- every 2 months to provide a minimum sure to Amblyomma americanum ticks. dose of 18.2 mg/lb (40 mg/kg) fluralaner (ii) Indications for use. Kills adult and 0.9 mg/lb (2 mg/kg) moxidectin. fleas; for the treatment and prevention (2) Indications for use. For the preven- of flea infestations (Ctenocephalides tion of heartworm disease caused by felis) and the treatment and control of Dirofilaria immitis and for the treatment tick infestations (Ixodes scapularis of infections with intestinal (black-legged tick), Dermacentor roundworm (Toxocara cati, 4th stage variabilis (American dog tick), and larvae, immature adults, and adults) Rhipicephalus sanguineus (brown dog and hookworm (Ancylostoma tubaeforme, tick)) for 12 weeks in dogs and puppies 4th stage larvae, immature adults, and 6 months of age and older, and weigh- adults); kills adult fleas and is indi- ing 4.4 lb or greater; for the treatment cated for the treatment and prevention and control of A. americanum (lone star tick) infestations for 8 weeks in dogs of flea infestations (Ctenocephalides and puppies 6 months of age and older, felis) and the treatment and control of and weighing 4.4 lb or greater. tick infestations (Ixodes scapularis (iii) Limitations. Federal law restricts (black-legged tick) and Dermacentor this drug to use by or on the order of a variabilis (American dog tick)) for 2 licensed veterinarian. months in cats and kittens 6 months of (2) Cats—(i) Amount. Administer topi- age and older and weighing 2.6 lb or cally as a single dose every 12 weeks greater. according to the label dosage schedule (3) Limitations. Federal law restricts to provide a minimum dose of 18.2 mg/ this drug to use by or on the order of a lb (40 mg/kg) body weight. May be ad- licensed veterinarian. ministered every 8 weeks in case of po- [85 FR 18120, Apr. 1, 2020] tential exposure to D. variabilis ticks. (ii) Indications for use. Kills adult § 524.1005 Furazolidone powder. fleas; for the treatment and prevention of flea infestations (C. felis) and the (a) Specifications. The product con- treatment and control of I. scapularis tains either 4 or 10 percent furazolidone (black-legged tick) infestations for 12 in inert dispersing agent and propel- weeks in cats and kittens 6 months of lant. age and older, and weighing 2.6 lb or (b) Sponsors. (1) See No. 051031 in greater; for the treatment and control § 510.600(c) of this chapter for use as in of D. variabilis (American dog tick) in- paragraphs (c)(1), (c)(2)(i), (c)(2)(ii), and festations for 8 weeks in cats and kit- (c)(3) of this section.

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(2) See No. 017135 for use of the 4 per- (c) Conditions of use in dogs and cats— cent product as in paragraph (c)(2)(iv) (1) Amount. Administer 1 or 2 drops into of this section. the conjunctival sac 2 to 4 times a day. (c) Conditions of use—(1) Amount. Hold (2) Indications for use. For the topical container about 6 to 12 inches from the treatment of infections of the con- eye or affected area and apply only junctiva caused by susceptible bac- enough powder to impart a light yellow teria. color. (3) Limitations. Federal law restricts (2) Indications of use—(i) Dogs. For this drug to use by or on the order of a treatment or prevention of bacterial licensed veterinarian. infection of superficial wounds, abra- sions, lacerations, and pyogenic derma- [80 FR 18776, Apr. 8, 2015] titis. (ii) Horses. For treatment or preven- § 524.1044b Gentamicin and betamethasone otic solution. tion of bacterial infection of superficial wounds, abrasions, lacerations, and fol- (a) Specifications. Each milliliter of lowing firing (heat or electrocautery). solution contains gentamicin sulfate (iii) [Reserved] equivalent to 3 milligrams (mg) (iv) Horses and ponies. For treatment gentamicin base and betamethasone or prevention of bacterial infection of valerate equivalent to 1 mg superficial wounds, abrasions, and lac- betamethasone alcohol. erations caused by Staphylococcus (b) Sponsors. See Nos. 000061 and aureus, Streptococcus spp. and Proteus 054925 in § 510.600(c) of this chapter. spp. sensitive to furazolidone. (c) Conditions of use—(1) Amounts and (3) Limitations. For topical applica- indications for use—(i) For the treat- tion in horses, ponies, and dogs: Clean ment of acute and chronic otitis affected area thoroughly, apply drug externa caused by bacteria sensitive to once or twice daily, and repeat treat- gentamicin in dogs, instill three to ment as required. Use only as rec- eight drops of solution into the ear ommended by a veterinarian in treat- canal twice daily for 7 to 14 days. ment of puncture wounds, wounds re- (ii) For the treatment of infected su- quiring surgical debridement or sutur- perficial lesions caused by bacteria ing, those of a chronic nature involving sensitive to gentamicin in dogs and proud flesh, generalized and chronic in- cats, apply a sufficient amount of the fections of the skin, and those skin drug to cover the treatment area twice conditions associated with intense daily for 7 to 14 days. itching. If redness, irritation, or swell- (2) Limitations. Federal law restricts ing persists or increases, discontinue this drug to use by or on the order of a use and consult a veterinarian. Do not licensed veterinarian. use in horses intended for human con- sumption. [71 FR 13542, Mar. 16, 2006]

[45 FR 49543, July 25, 1980, as amended at 50 § 524.1044c Gentamicin ophthalmic FR 30153, July 24, 1985; 56 FR 50653, Oct. 8, 1991; 57 FR 31314, July 15, 1992; 60 FR 55659, ointment. Nov. 2, 1995; 65 FR 41588, July 6, 2000; 79 FR (a) Specifications. Each gram of oint- 10969, Feb. 27, 2014; 82 FR 11508, Feb. 24, 2017] ment contains gentamicin sulfate equivalent to 3 milligrams of § 524.1044 Gentamicin ophthalmic and gentamicin. topical dosage forms. (b) Sponsors. See Nos. 000061 and § 524.1044a Gentamicin ophthalmic so- 026637 in § 510.600(c) of this chapter. lution. (c) Conditions of use in dogs and cats— (a) Specifications. Each milliliter of (1) Amount. Apply approximately a 1/2- solution contains gentamicin sulfate inch strip to the affected eye 2 to 4 equivalent to 3 milligrams of times a day. gentamicin. (2) Indications for use. For treatment (b) Sponsors. See Nos. 000061 and of conjunctivitis caused by susceptible 059399 in § 510.600(c) of this chapter. bacteria.

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(3) Limitations. Federal law restricts similar signs. If conditions persists or this drug to use by or on the order of a increases, discontinue use and consult licensed veterinarian. a veterinarian. [69 FR 47363, Aug. 5, 2004, as amended at 77 [48 FR 41157, Sept. 14, 1983, as amended 52 FR FR 64717, Oct. 23, 2012; 85 FR 4208, Jan. 24, 7833, Mar. 13, 1987; 79 FR 10969, Feb. 27, 2014; 2020] 84 FR 32993, July 11, 2019]

§ 524.1044d Gentamicin and § 524.1044f Gentamicin and betamethasone ointment. betamethasone spray. (a) Specifications. Each gram of oint- (a) Specifications. Each milliliter of ment contains gentamicin sulfate spray contains gentamicin sulfate equivalent to 3 milligrams of equivalent to 0.57 milligram (mg) gentamicin base and betamethasone gentamicin base and equivalent to 1 milligram of valerate equivalent to 0.284 mg betamethasone. betamethasone. (b) Sponsor. See No. 000061 in (b) Sponsors. See Nos. 000061, 054925, § 510.600(c) of this chapter. 058005, and 058829 in § 510.600(c) of this (c) Conditions of use in dogs—(1) chapter. Amount—(i) Otitis externa. Instill 3 to 8 (c) Conditions of use in dogs—(1) drops into the ear canal twice daily for Amount. Hold bottle upright 3 to 6 7 days. inches from the lesion and depress the (ii) Infected superficial lesions. Apply sprayer head twice. Administer two to cover the treatment area twice daily spray actuations two to four times for 7 to 14 days. daily for 7 days. (2) Indications for use. For the treat- (2) Indications for use. For the treat- ment of acute and chronic otitis ment of infected superficial lesions externa and infected superficial lesions caused by bacteria susceptible to caused by bacteria sensitive to gentamicin. gentamicin. (3) Limitations. Federal law restricts (3) Limitations. Federal law restricts this drug to use by or on the order of a this drug to use by or on the order of a licensed veterinarian. licensed veterinarian. [71 FR 13542, Mar. 16, 2006, as amended at 72 [47 FR 26378, June 18, 1982, as amended at 52 FR 5929, Feb. 8, 2007; 74 FR 22822, May 15, FR 7832, Mar. 13, 1987; 79 FR 10969, Feb. 27, 2009; 77 FR 3598, Jan. 25, 2012; 85 FR 4208, Jan. 2014] 24, 2020]

§ 524.1044e Gentamicin spray. § 524.1044g Gentamicin, (a) Specification. Each milliliter of betamethasone, and clotrimazole sterile aqueous solution contains ointment. gentamicin sulfate equivalent to 1.07 (a) Specifications. Each gram (g) of milligrams of gentamicin. ointment contains gentamicin sulfate (b) Sponsor. See No. 000061 in equivalent to 3 milligrams (mg) § 510.600(c) of this chapter. gentamicin base, betamethasone val- (c) Related tolerances. See § 556.300 of erate equivalent to 1 mg this chapter. betamethasone, and 10 mg (d) Conditions of use in cattle—(1) clotrimazole. Amount. Hold the sprayer upright 3 to 6 (b) Sponsors. See sponsors in inches from the affected eye, with the § 510.600(c) of this chapter for uses as in opening directed towards the eye, and paragraph (c) of this section. pump once. Treat once daily for up to (1) No. 000061 for use of 7.5- or 15-gram 3 days. (g) tubes, 12.5-, 30-, or 215-g bottles. (2) Indications for use. For the treat- (2) No. 054925 for use of 7.5- or 15-g ment of pinkeye in cattle (infectious tubes; 10-, 15-, 25-, or 215-g bottles. bovine keratoconjunctivitis) caused by (3) No. 069043 for use of 10-, 20-, 40-, or Moraxella bovis. 215-g bottles. (3) Limitations. Conditions other than (4) No. 025463 for use of 7.5- or 15-g bacterial infections of the bovine eye tubes, or 215-g bottles. and infectious keratoconjunctivitis (c) Conditions of use in dogs—(1) caused by Moraxella bovis may produce Amount. Instill ointment twice daily

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into the ear canal for 7 consecutive Proteus mirabilis, and beta-hemolytic days. streptococci). (i) From 7.5- or 15-g tubes; 10-, 12.5-, (3) Limitations. Federal law restricts 15-, 25-, or 30-g bottles: 4 drops for dogs this drug to use by or on the order of a weighing less than 30 pounds (lb) or 8 licensed veterinarian. drops for dogs weighing 30 lb or more. (ii) From 20-, 40-, or 215-g bottles: 2 [66 FR 712, Jan. 4, 2001, as amended at 68 FR drops for dogs weighing less than 30 lb 15370, Mar. 31, 2003; 70 FR 36338, June 23, 2005; or 4 drops for dogs weighing 30 lb or 79 FR 10969, Feb. 27, 2014; 81 FR 59134, Aug. 29, 2016] more. (ii) From 20- or 215-g bottles: 2 drops § 524.1044i Gentamicin and for dogs weighing less than 30 lb or 4 betamethasone ophthalmic solution. drops for dogs weighing 30 lb or more. (2) Indications for use. For the treat- (a) Specifications. Each milliliter ment of acute and chronic canine otitis (mL) of solution contains gentamicin externa associated with yeast sulfate equivalent to 3 milligrams (mg) (Malassezia pachydermatis, formerly of gentamicin base and 1 mg Pityrosporum canis) and/or bacteria sus- betamethasone acetate equivalent to ceptible to gentamicin. 0.89 mg betamethasone alcohol. (3) Limitations. Federal law restricts (b) Sponsor. See No. 000061 in this drug to use by or on the order of a § 510.600(c) of this chapter. licensed veterinarian. (c) Conditions of use in dogs—(1) [58 FR 38973, July 21, 1993, as amended at 63 Amount. Instill one or two drops of so- FR 31932, June 11, 1998; 68 FR 42970, July 21, lution in the conjunctival sac three or 2003; 70 FR 8291, Feb. 18, 2005; 71 FR 13542, four times a day. Mar. 16, 2006; 71 FR 16481, Apr. 3, 2006; 71 FR (2) Indications for use. For treatment 38261, July 6, 2006; 71 FR 56867, Sept. 28, 2006; of external eye infections and inflam- 78 FR 17597, Mar. 22, 2013; 79 FR 10969, Feb. 27, 2014; 81 FR 17608, Mar. 30, 2016] mation. (3) Limitations. Federal law restricts § 524.1044h Gentamicin, mometasone, this drug to use by or on the order of a and clotrimazole otic suspension. licensed veterinarian. (a) Specifications. Each gram of sus- [75 FR 54492, Sept. 8, 2010, as amended at 80 pension contains gentamicin sulfate, FR 13230, Mar. 13, 2015] United States Pharmacopeia (USP) equivalent to 3 milligram (mg) § 524.1132 Hydrocortisone, miconazole, gentamicin base, mometasone furoate and gentamicin otic suspension. monohydrate or mometasone furoate (a) Specifications. Each milliliter anhydrous, USP, equivalent to 1 mg (mL) of suspension contains 1.11 milli- mometasone, and 10 mg clotrimazole, grams (mg) , USP. 17.4 mg miconazole nitrate, and 1.5 mg (b) Sponsors. See Nos. 000061 and 054925 in § 510.600(c) of this chapter. gentamicin (as gentamicin sulfate). (c) Conditions of use in dogs—(1) (b) Sponsor. See No.051311 in Amount. For dogs weighing less than 30 § 510.600(c) of this chapter. pounds (lb), instill 4 drops from the 7.5- (c) Conditions of use in dogs—(1) , 15-, or 30-gram (g) bottle into the ear Amount. Instill 1.0 mL in the affected canal (2 drops from the 215-g bottle) or, ear once daily for 5 days. for dogs weighing 30 lb or more, instill (2) Indications for use. For the treat- 8 drops from the 7.5-, 15-, or 30-g bottle ment of otitis externa in dogs associ- into the ear canal (4 drops from the 215- ated with susceptible strains of yeast g bottle), once or twice daily for 7 days. (Malassezia pachydermatis) and bacteria (2) Indications for use. For the treat- (Staphylococcus pseudintermedius). ment of otitis externa caused by sus- (3) Limitations. Federal law restricts ceptible strains of yeast (Malassezia this drug to use by or on the order of a pachydermatis) and bacteria licensed veterinarian. (Pseudomonas spp. [including P. aeruginosa], coagulase-positive [76 FR 78150, Dec. 16, 2011, as amended at 83 staphylococci, Enterococcus faecalis, FR 13635, Mar. 30, 2018]

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§ 524.1140 Imidacloprid and stenocephala), and whipworms (Trichuris ivermectin. vulpis); kills adult fleas and treats flea (a) Specifications. The product is infestations (Ctenocephalides felis). available in unit applicator tubes con- (B) For treatment of Dirofilaria taining 0.4, 1.0, 2.5, or 4.0 milliliters immitis circulating microfilariae in (mL). Each mL of solution contains 100 heartworm-positive dogs and the treat- milligrams (mg) imidacloprid and 800 ment and control of sarcoptic mange micrograms (μg) ivermectin. caused by Sarcoptes scabiei var. canis. (b) Sponsor. See No. 000859 in (2) Cats—(i) Amount. Topically apply § 510.600(c) of this chapter. 4.5 mg/lb body weight (10 mg/kg) (c) Conditions of Use in Dogs—(1) imidacloprid and 0.45 mg/lb (1.0 mg/kg) Amount. The recommended minimum moxidectin, once a month. dosage is 4.5 mg/pound (lb) (10 mg/kilo- (ii) Indications for use. For the pre- gram (kg)) of imidacloprid and 36.4 μg/ vention of heartworm disease caused lb (80 μg/kg) of ivermectin, topically by Dirofilaria immitis; for the treatment once a month. and control of (Otodectes (2) Indications for Use. For the preven- cynotis) infestations, intestinal tion of heartworm disease caused by roundworms (Toxocara cati), and Dirofilaria immitis; kills adult fleas and hookworms (Ancylostoma tubaeforme); is indicated for the treatment of flea kills adult fleas and treats flea infesta- infestations (Ctenocephalides felis). tions (Ctenocephalides felis). (3) Limitations. Federal law restricts (3) Ferrets—(i) Amount. Topically this drug to use by or on the order of a apply 9.0 mg/lb body weight (20 mg/kg) licensed veterinarian. imidacloprid and 0.9 mg/lb (2 mg/kg) [67 FR 78685, Dec. 26, 2002] moxidectin, once a month. (ii) Indications for use. For the pre- § 524.1146 Imidacloprid and vention of heartworm disease caused moxidectin. by Dirofilaria immitis; kills adult fleas (a) Specifications. Each milliliter of (Ctenocephalides felis) and is indicated solution contains: for the treatment of flea infestations (1) 100 milligrams (mg) imidacloprid on ferrets. and 25 mg moxidectin; or (2) 100 mg imidacloprid and 10 mg [72 FR 10597, Mar. 9, 2007, as amended at 78 moxidectin. FR 73698, Dec. 9, 2013; 85 FR 18120, Apr. 1, (b) Sponsors. See sponsor numbers in 2020] § 510.600(c) of this chapter as follows: (1) Nos. 000859 and 017030 for use of § 524.1193 Ivermectin topical solution. product described in paragraph (a)(1) of (a) Specifications. Each milliliter this section as in paragraph (d)(1) of (mL) of solution contains 5 milligrams this section. of ivermectin. (2) No. 000859 for use of product de- (b) Sponsors. See sponsors in scribed in paragraph (a)(2) of this sec- § 510.600(c) of this chapter for use as in tion as in paragraphs (d)(2) and (3) of paragraph (e) of this section. this section. (1) Nos. 000010, 055529, 058829, 061133 (c) Special considerations. Federal law for use as in paragraphs (e)(1), (e)(2)(i), restricts this drug to use by or on the (e)(2)(iii), and (e)(3) of this section. order of a licensed veterinarian. (d) Conditions of use—(1) Dogs—(i) (2) Nos. 016592, 054925, and 058005 for Amount. Topically apply 4.5 mg/lb body use as in paragraphs (e)(1), (e)(2)(i), weight (10 mg/kg) imidacloprid and 1.1 (e)(2)(ii), and (e)(3) of this section. mg/lb (2.5 mg/kg) moxidectin, once a (c) Related tolerances. See § 556.344 of month. this chapter. (ii) Indications for use. (A) For the (d) Special considerations. See § 500.25 prevention of heartworm disease of this chapter. caused by Dirofilaria immitis; and the (e) Conditions of use in cattle—(1) treatment and control of intestinal Amount. One mL per 22 pounds (0.5 mil- roundworms ( and ligram per kilogram) of body weight Toxascaris leonina), hookworms applied topically to the back of the (Ancylostoma caninum and Uncinaria animal.

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(2) Indications for use—(i) It is used (c) Conditions of use—(1) Amount. Ad- for the treatment and control of: Gas- minister the contents of one 0.5-mL trointestinal roundworms (adults and tube topically into each external ear fourth-stage larvae) Ostertagia ostertagi canal. (including inhibited stage), Haemonchus (2) Indications for use. For the treat- placei, Trichostrongylus axei, T. ment of adult ear mite (Otodectes colubriformis, Cooperia oncophora, C. cynotis) infestations in cats and kittens punctata, C. surnabada, 4 weeks of age and older. Effectiveness Oesophagostomum radiatum; (adults) against eggs and immature stages has Strongyloides papillosus, Trichuris spp.; not been proven. lungworms (adults and fourth-stage larvae) Dictyocaulus viviparus; cattle (3) Limitations. Federal law restricts grubs (parasitic stages) Hypoderma this drug to use by or on the order of a bovis, H. lineatum; mites Sarcoptes licensed veterinarian. scabiei var. bovis; lice Linognathus vituli, [66 FR 7578, Jan. 24, 2001, as amended at 74 Haematopinus eurysternus, Damalinia FR 26782, June 4, 2009] bovis, Solenoptes capillatus; and horn flies Haematobia irritans. § 524.1200 Kanamycin ophthalmic and (ii) It controls infections and pre- topical dosage forms. vents reinfection with O. ostertagi, O. radiatum, H. placei, T. axei, C. punctata, § 524.1200a Kanamycin ophthalmic and C. oncophora for 14 days after ointment. treatment. (a) Specifications. Each gram of oint- (iii) It controls infections and pre- ment contains 3.5 milligrams vents reinfection with O. radiatum and kanamycin activity as kanamycin sul- D. viviparus for 28 days after treatment, fate. and for 21 days after C. punctata T. axei (b) Sponsor. See No. 054771 in treatment, O. ostertagi, H. placei, C. § 510.600(c) of this chapter. oncophora, and C. surnabada for 14 days after treatment, and D. bovis for 56 (c) Conditions of use in dogs—(1) days after treatment. Amount. Apply a thin film to the af- (3) Limitations. Do not treat cattle fected eye three or four times daily or within 48 days of slaughter. Because a more frequently if deemed advisable. withdrawal time in milk has not been Treatment should be continued for at established, do not use in female dairy least 48 hours after the eye appears cattle of breeding age. A withdrawal normal. period has not been established for this (2) Indications for use. For the treat- product on preruminating calves. Do ment of various eye infections (con- not use on calves to be processed for junctivitis, blepharitis, dacryocystitis, veal. keratitis, and corneal ulcerations) due [55 FR 50551, Dec. 7, 1990, as amended at 62 to bacteria sensitive to kanamycin. FR 38908, July 21, 1997; 62 FR 63271, Nov. 28, For prophylaxis in traumatic condi- 1997; 63 FR 44385, Aug. 19, 1998; 66 FR 13236, tions, removal of foreign bodies, and Mar. 5, 2001; 66 FR 63165, Dec. 5, 2001; 68 FR intraocular surgery. 3817, Jan. 27, 2003; 68 FR 4713, Jan. 30, 2003; 69 (3) Limitations. Federal law restricts FR 501, Jan. 6, 2004; 69 FR 62181, Oct. 25, 2004; 71 FR 13542, Mar. 16, 2006; 72 FR 6464, Feb. 12, this drug to use by or on the order of a 2007; 74 FR 36112, July 22, 2009; 75 FR 26648, licensed veterinarian. May 12, 2010; 76 FR 81807, Dec. 29, 2011; 78 FR [79 FR 10969, Feb. 27, 2014] 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, § 524.1200b Kanamycin ophthalmic so- Aug. 9, 2019] lution. (a) Specifications. Each milliliter of § 524.1195 Ivermectin otic suspension. solution contains 10 milligrams (a) Specifications. Each tube contains kanamycin activity as kanamycin sul- 0.5 milliliter (mL) of a 0.01 percent sus- fate. pension of ivermectin. (b) Sponsor. See No. 054771 in (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. § 510.600(c) of this chapter.

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(c) Conditions of use in dogs—(1) liter of diethylene glycol monobutyl Amount. Instill a few drops into the af- ether (DGME) solution. fected eye every 3 hours or more fre- (b) Sponsors. See Nos. 000061 and quently if deemed advisable. Admin- 054771 in § 510.600(c) of this chapter. ister as frequently as possible for the (c) Related tolerances. See § 556.350 of first 48 hours, after which the fre- this chapter. quency of applications may be de- (d) Conditions of use. Cattle—(1) creased. Treatment should be contin- Amount. 2.5 milliliters per 110 pounds ued for at least 48 hours after the eye (10 milligrams of levamisole per kilo- appears normal. gram) of body weight as a single dose (2) Indications for use. For the treat- topically to the back of the animal. ment of various eye infections (con- (2) Indications for use. junctivitis, blepharitis, dacryocystitis, effective against stomach worms keratitis, and corneal ulcerations) due (Haemonchus, Trichostrongylus, to bacteria sensitive to kanamycin. Ostertagia), intestinal worms For prophylaxis in traumatic condi- (Trichostrongylus, Cooperia, tions, removal of foreign bodies, and Nematodirus, Bunostomum, intraocular surgery. Oesophagostomum, Chabertia), and (3) Limitations. Federal law restricts lungworms (Dictyocaulus). this drug to use by or on the order of a (3) Limitations. Conditions of constant licensed veterinarian. helminth exposure may require re- [79 FR 10970, Feb. 27, 2014] treatment within 2 to 4 weeks after the first treatment. Cattle must not be § 524.1204 Kanamycin, amphomycin, slaughtered within 9 days following and hydrocortisone ointment. last treatment. Do not administer to (a) Specifications. Each gram of oint- dairy animals of breeding age. Do not ment contains 5 milligrams kanamycin treat animals before dipping or prior to activity as kanamycin sulfate, 5 milli- exposure to heavy rain. Consult your grams of amphomycin activity as the veterinarian for assistance in the diag- calcium salt, and 10 milligrams of hy- nosis, treatment, and control of para- drocortisone acetate. sitism, and before using in severely de- (b) Sponsor. See No. 054771 in bilitated animals. § 510.600(c) of this chapter. [52 FR 10887, Apr. 6, 1987, as amended at 53 (c) Conditions of use in dogs—(1) FR 7504, Mar. 9, 1988; 62 FR 61626, Nov. 19, Amount. Apply to the affected areas of 1997; 67 FR 78355, Dec. 24, 2002; 79 FR 10970, the skin at least twice daily. In severe Feb. 27, 2014] or widespread lesions it may be desir- able to apply the ointment more than § 524.1376 2-Mercaptobenzothiazole so- twice daily. After some improvement is lution. observed, treatment can usually be re- (a) Specifications. The drug contains duced to once daily. 1.3 percent 2-mercaptobenzothiazole in (2) Indications for use. For the treat- a suitable solvent. ment of acute otitis externa, furuncu- (b) Sponsor. See 017135 in § 510.600(c) of losis, folliculitis, pruritus, anal gland this chapter. infections, erythema, decubital ulcers, (c) Conditions of use—(1) Amount. superficial wounds, and superficial ab- Apply twice daily to affected area. scesses associated with bacterial infec- (2) Indications for use. For dogs as an tions caused by organisms susceptible aid in the treatment of hot spots to one or both antibiotics. (moist dermatitis) and as first aid for (3) Limitations. Federal law restricts scrapes and abrasions. this drug to use by or on the order of a (3) Limitations. Clip hair from affected licensed veterinarian. area before applying. If no improve- [79 FR 10970, Feb. 27, 2014] ment is seen within 1 week, consult a veterinarian. § 524.1240 Levamisole. [48 FR 15618, Apr. 12, 1983, as amended at 65 (a) Specifications. The drug contains FR 50913, Aug. 22, 2000; 68 FR 33381, June 4, 200 milligrams of levamisole per milli- 2003]

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§ 524.1443 Miconazole. § 524.1446 Milbemycin otic solution. (a) Specifications. (1) Each gram of (a) Specifications. Each tube contains cream contains miconazole nitrate 0.25 milliliter of a 0.1 percent solution equivalent to 20 milligrams miconazole of . base. (b) Sponsor. See No. 058198 in (2) Each gram of lotion or spray con- § 510.600(c) of this chapter. tains miconazole nitrate equivalent to (c) Conditions of use—(1) Amount. One 1 percent miconazole base. tube administered topically into each (b) Sponsors. See § 510.600(c) of this external ear canal. chapter for use as in paragraph (c) of (2) Indications for use. For the treat- this section: ment of ear mite (Otodectes cynotis) in- (1) No. 000061 for use of cream, lotion, festations in cats and kittens 4 weeks and spray; of age and older. Effectiveness is main- (2) Nos. 054925 and 058829 for use of lo- tained throughout the life cycle of the tion and spray. ear mite. (c) Conditions of use in dogs and cats— (3) Limitations. Federal law restricts (1) Amount. Apply once daily by rub- this drug to use by or on the order of a bing into or spraying a light covering licensed veterinarian. on the infected site and the immediate surrounding vicinity. Continue treat- [65 FR 13905, Mar. 15, 2000, as amended at 66 ment for 2 to 4 weeks until infection is FR 13849, Mar. 8, 2001] completely eradicated as determined by appropriate laboratory examina- § 524.1448 Mirtazapine transdermal tion. ointment. (2) Indications for use. For topical (a) Specifications. Each gram of oint- treatment of infections caused by ment contains 20 milligrams (mg) Microsporum canis, Microsporum mirtazapine. gypseum, and Trichophyton (b) Sponsor. See No. 086078 in mentagrophytes. § 510.600(c) of this chapter. (3) Limitations. Federal law restricts (c) Conditions of use—(1) Amount. Ad- this drug to use by or on the order of a minister topically by applying a 1.5 licensed veterinarian. inch ribbon of ointment (approxi- [71 FR 13542, Mar. 16, 2006] mately 2 mg) on the inner pinna of the cat’s ear once daily for 14 days. Alter- § 524.1445 Miconazole, polymixin B, nate the daily application of ointment and prednisolone suspension. between the left and right inner pinna (a) Specifications. Each milliliter of of the ears. suspension contains 23 milligrams (mg) (2) Indications for use. For the man- miconazole nitrate, 0.5293 mg agement of weight loss in cats. polymixin B sulfate, and 5 mg prednis- (3) Limitations. Federal law restricts olone acetate. this drug to use by or on the order of a (b) Sponsor. See No. 058198 in licensed veterinarian. § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) [83 FR 64740, Dec. 18, 2018] Amount. Instill five drops in the ear § 524.1450 Moxidectin. canal twice daily for 7 consecutive days. (a) Specifications. Each milliliter of (2) Indications for use. For the treat- solution contains: ment of canine otitis externa associ- (1) 5 milligrams (mg) moxidectin (0.5 ated with susceptible strains of yeast percent solution). (Malassezia pachydermatis) and bacteria (2) 25 mg moxidectin (2.5 percent so- (Staphylococcus pseudintermedius). lution). (3) Limitations. Federal law restricts (b) Sponsors. See sponsor numbers in this drug to use by or on the order of a § 510.600 of this chapter: licensed veterinarian. (1) No. 000859 for use of product de- [ 75 FR 4693, Jan. 29, 2010, as amended at 77 scribed in paragraph (a)(1) of this sec- FR 46613, Aug. 6, 2012; 81 FR 48703, July 26, tion as in paragraph (d)(1) of this sec- 2016] tion;

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(2) No. 000859 for use of product de- that are at least 7 weeks of age and scribed in paragraph (a)(2) of this sec- that weigh at least 3 lbs. tion as in paragraph (d)(2) of this sec- (iii) Limitations. Federal law restricts tion. this drug to use by or on the order of a (c) Related tolerances. See § 556.426 of licensed veterinarian. this chapter. [63 FR 14036, Mar. 24, 1998, as amended at 65 (d) Conditions of use—(1) Cattle—(i) FR 36617, June 9, 2000; 66 FR 46370, Sept. 5, Amount. Administer topically 0.5 mg 2001. Redesignated at 76 FR 48715, Aug. 9, per kilogram (kg) of body weight. 2011, as amended at 80 FR 53460, Sept. 4, 2015; (ii) Indications for use. Beef and dairy 82 FR 21691, May 10, 2017] cattle: For treatment and control of in- ternal and external parasites: gastro- § 524.1465 Mupirocin. intestinal roundworms (Ostertagia (a) Specifications. Each gram of oint- ostertagi (adult and L4, including inhib- ment contains 20 milligrams ited larvae), Haemonchus placei (adult mupirocin. and L4), Trichostrongylus axei (adult (b) Sponsors. See Nos. 025463, 051672, and L4), T. colubriformis (adult and L4), and 054771 in § 510.600(c) of this chapter. Cooperia oncophora (adult and L4), C. (c) Conditions of use in dogs—(1) pectinata (adult), C. punctata (adult and Amount. Apply twice daily. Treatment L4), C. spatulata (adult), C. surnabada should not exceed 30 days. (adult and L4), Bunostomum (2) Indications for use. For the topical phlebotomum (adult), Oesophagostomum treatment of bacterial infections of the radiatum (adult and L4), Nematodirus skin, including superficial pyoderma, helvetianus (adult and L4)); lungworms caused by susceptible strains of Staphy- (Dictyocaulus viviparus (adult and L4)); lococcus aureus and S. intermedius. cattle grubs (Hypoderma bovis, H. (3) Limitations. Federal law restricts lineatum); mites (Chorioptes bovis, this drug to use by or on the order of a Psoroptes ovis (P. communis var. bovis)); licensed veterinarian. lice (Linognathus vituli, Haematopinus [72 FR 18119, Apr. 11, 2007, as amended at 75 eurysternus, Solenopotes capillatus, FR 79296, Dec. 20, 2010; 78 FR 52854, Aug. 27, Bovicola (Damalinia) bovis); and horn 2013; 79 FR 10970, Feb. 27, 2014; 82 FR 11508, flies (Haematobia irritans). To control Feb. 24, 2017] infections and to protect from reinfec- tion with H. placei for 14 days after § 524.1484 Neomycin ophthalmic and topical dosage forms. treatment, O. radiatum and O. ostertagi for 28 days after treatment, and D. § 524.1484b Neomycin, isoflupredone, viviparus for 42 days after treatment. tetracaine, and myristyl-gamma- (iii) Limitations. A withdrawal period picolinium powder. has not been established for this prod- (a) Specifications. The product con- uct on preruminating calves. Do not tains 5 milligrams of neomycin sulfate, use on calves to be processed for veal. equivalent to 3.5 milligrams of neomy- See § 500.25 of this chapter. cin base, 1 milligram of isoflupredone (2) Dogs—(i) Amount. Administer topi- acetate, 5 milligrams of tetracaine hy- cally a minimum of 1.1 mg per pound drochloride and .2 milligram of (lb) (2.5 mg/kg) of body weight, once myristyl-gamma-picolinium chloride monthly using the appropriate pre- in each gram of the product in a special loaded applicator tube. adherent powder base. (ii) Indications for use. For the pre- (b) Sponsor. See No. 054771 in vention of heartworm disease caused § 510.600(c) of this chapter. by Dirofilaria immitis, as well as the (c) Conditions of use in horses, dogs, treatment and control of intestinal and cats—(1) Amount. Apply to affected hookworm (Ancylostoma caninum areas as a dusting powder. (adult, immature adult, and L4 larvae) (2) Indications for use. For the treat- and Uncinaria stenocephala (adult, im- ment or as adjunctive therapy of cer- mature adult, and L4 larvae)), tain ear and skin conditions caused by roundworm (Toxocara canis (adult and or associated with neomycin-suscep- L4 larvae) and Toxascaris leonina tible organisms and/or allergy; as a su- (adult)), and whipworm (Trichuris vulpis perficial dressing applied to minor (adult)) infections in dogs and puppies cuts, wounds, lacerations, abrasions,

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and for postsurgical application where (3) Limitations. Federal law restricts reduction of pain and inflammatory re- this drug to use by or on the order of a sponse is deemed desirable; as a dust- licensed veterinarian. ing powder following amputation of [40 FR 13873, Mar. 27, 1975, as amended at 43 tails, claws, and dewclaws and fol- FR 18172, Apr. 28, 1978; 79 FR 10970, Feb. 27, lowing ear trimming, castrating, and 2014] such surgical procedures as ovariohysterectomies. For the treat- § 524.1484d Neomycin, hydrocortisone, and tetracaine otic ointment. ment of acute otitis externa, acute moist dermatitis, and interdigital der- (a) Specifications. The product con- matitis in dogs. tains 5 milligrams of neomycin sulfate, equivalent to 3.5 milligrams of neomy- (3) Limitations. Federal law restricts cin base, 5 milligrams of hydro- this drug to use by or on the order of a , and 5 milligrams of licensed veterinarian. tetracaine hydrochloride in each gram [40 FR 13873, Mar. 27, 1975, as amended at 43 of ointment. FR 18172, Apr. 28, 1978; 79 FR 10970, Feb. 27, (b) Sponsor. See No. 054771 in 2014] § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— § 524.1484c Neomycin, isoflupredone, (1) Amount. Instill a quantity of oint- and tetracaine ointment. ment sufficient to fill the external ear (a) Specifications. The drug contains 5 canal; may be applied one to three milligrams of neomycin sulfate (equiv- times daily. alent to 3.5 milligrams of neomycin (2) Indications for use. For the treat- ment of ear canker and other inflam- base), 1 milligram of isoflupredone ace- matory conditions of the external ear tate, and 5 milligrams of tetracaine hy- canal, acute otitis externa and, to a drochloride in each gram of ointment. lesser degree, chronic otitis externa. (b) Sponsor. See No. 054771 in (3) Limitations. Federal law restricts § 510.600(c) of this chapter. this drug to use by or on the order of a (c) Conditions of use in dogs—(1) licensed veterinarian. Amount. In treatment of otitis externa [40 FR 13873, Mar. 27, 1975, as amended at 49 and other inflammatory conditions of FR 21922, May 24, 1984; 79 FR 10970, Feb. 27, the external ear canal, a quantity of 2014] ointment sufficient to fill the external ear canal; may be applied one to three § 524.1484e Neomycin and polymyxin B times daily. When used on the skin or ophthalmic solution. mucous membranes, the affected area (a) Specifications. Each milliliter of should be cleansed, and a small amount the ophthalmic preparation contains of the ointment applied and spread or 5.0 milligrams neomycin sulfate (3.5 rubbed in gently. The involved area milligrams neomycin base), and 10,000 may be treated one to three times a Units of polymyxin B sulfate. day and these daily applications con- (b) Sponsor. See No. 054771 in tinued in accordance with the clinical § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) response. Amount. Instill 1 to 2 drops per eye (2) Indications for use. For the treat- every 6 hours. ment of acute otitis externa in dogs (2) Indications for use. For the treat- and to a lesser degree, chronic otitis ment of bacterial infections associated externa in dogs. It also is effective in with topical ophthalmological condi- treating anal gland infections and tions such as corneal injuries, super- moist dermatitis in the dog and is a ficial keratitis, conjunctivitis, useful dressing for minor cuts, lacera- keratoconjunctivitis, and blepharitis. tions, abrasions, and post-surgical (3) Limitations. Federal law restricts therapy in the horse, cat, and dog. It this drug to use by or on the order of a may also be used following amputation licensed veterinarian. of dewclaws, tails and claws, following [40 FR 13873, Mar. 27, 1975, as amended at 61 ear trimming and castrating oper- FR 5507, Feb. 13, 1996; 79 FR 10970, Feb. 27, ations. 2014]

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§ 524.1484f Neomycin, prednisolone, § 524.1484h Neomycin, penicillin, poly- and tetracaine otic suspension. myxin B, and hydrocortisone sus- pension. (a) Specifications. The product con- tains 5 milligrams of neomycin sulfate (a) Specifications. Each milliliter of equivalent to 3.5 milligrams of neomy- suspension contains 25 milligrams of cin base, 2.5 milligrams of prednisolone neomycin sulfate equivalent to 17.5 milligrams of neomycin, 10,000 inter- acetate, and 5 milligrams of tetracaine national units of penicillin G procaine, hydrochloride in each milliliter of ster- 5,000 international units of polymyxin ile suspension. B sulfate, 2 milligrams of hydro- (b) Sponsor. See No. 054771 in cortisone acetate, and 1.25 milligrams § 510.600(c) of this chapter. of hydrocortisone sodium succinate. (c) Conditions of use in dogs and cats— (b) Sponsor. See No. 054771 in (1) Amount. Instill 2 to 6 drops in the § 510.600(c) of this chapter. external ear canal 2 or 3 times daily. (c) Conditions of use in dogs—(1) (2) Indications for use. For the treat- Amount. Rub a small amount into the ment of acute otitis externa and, to a affected area 1 to 3 times a day. After lesser degree, chronic otitis externa; as definite improvement, apply once daily treatment or adjunctive therapy of cer- or every other day. tain ear conditions caused by or associ- (2) Indications for use. For the treat- ated with neomycin-susceptible orga- ment of summer eczema, atopic derma- titis, interdigital eczema, and otitis nisms and/or allergy. externa caused by bacteria susceptible (3) Limitations. Federal law restricts to neomycin, penicillin, and polymyxin this drug to use by or on the order of a B. licensed veterinarian. (3) Limitations. Federal law restricts [40 FR 13873, Mar. 27, 1975, as amended at 79 this drug to use by or on the order of a FR 10971, Feb. 27, 2014] licensed veterinarian. (d) Conditions of use—dogs—(1) § 524.1484g Neomycin, thiabendazole, Amount. Rub a small amount into the and dexamethasone solution. involved area 1 to 3 times a day. After definite improvement, it may be ap- (a) Specifications. Each milliliter of plied once a day or every other day. solution contains 40 milligrams (mg) (2) Indications for use. Treatment of thiabendazole, 3.2 mg neomycin (from summer eczema, atopic dermatitis, neomycin sulfate), and 1 mg dexa- interdigital eczema, and otitis externa . caused by bacteria susceptible to neo- (b) Sponsors. See Nos. 000010 and mycin, penicillin, and polymyxin B. 026637 in § 510.600(c) of this chapter. (3) Limitations. For use in dogs only. (c) Conditions of use in dogs and cats— Shake drug thoroughly and clean le- (1) Amount. In treating dermatoses af- sion before using. If redness, irritation, fecting areas other than the ear, the or swelling persists or increases, dis- surface of the lesions should be well continue use and reevaluate diagnosis. moistened (2 to 4 drops per square inch) Federal law restricts this drug to use twice daily. In treating otitis externa, by or on the order of a licensed veteri- instill 5 to 15 drops in the ear twice narian. daily. Treat for up to 7 days. [59 FR 5105, Feb. 3, 1994, as amended at 79 FR (2) Indications for use. As an aid in the 10971, Feb. 27, 2014] treatment of bacterial, mycotic, and inflammatory dermatoses and otitis § 524.1484i Neomycin and hydro- externa. cortisone ointment. (3) Limitations. Federal law restricts (a) Specifications. The drug contains 5 this drug to use by or on the order of a milligrams of neomycin sulfate, equiv- licensed veterinarian. alent to 3.5 milligrams of neomycin base, and 5 milligrams of hydro- [40 FR 13873, Mar. 27, 1975, as amended at 62 cortisone acetate in each gram of oint- FR 63271, Nov. 28, 1997; 79 FR 10971, Feb. 27, ment.1 2014; 80 FR 61297, Oct. 13, 2015; 84 FR 39184, (b) Sponsor. See No. 054771 in Aug. 9, 2019] § 510.600(c) of this chapter.

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(c) Conditions of use in dogs and cats— of neomycin sulfate equivalent to 3.5 (1) Amount. Apply 3 or 4 times daily milligrams of neomycin base. into the conjunctival sac. With im- (b) Sponsor. See No. 054771 in provement, frequency may be reduced § 510.600(c) of this chapter. to 2 or 3 times daily. For treatment of (c) Conditions of use in dogs and cats— ear canker and other inflammatory (1) Amount. For beginning treatment of conditions of the external ear canal, acute ocular inflammations place 1 or 2 fill external ear canal 1 to 3 times drops in the conjunctival sac 3 to 6 daily. times during a 24 hour period. When (2) Indications for use. For the treat- improvement occurs, reduce the dosage ment of infections, allergic and trau- to 1 drop 2 to 4 times daily. For otitis matic keratitis, conjunctivitis, acute externa, place 2 to 6 drops in the exter- otitis externa and, to a lesser degree, nal ear canal 2 or 3 times daily. chronic otitis externa. (2) Indications for use. For the treat- (3) Limitations. Federal law restricts ment of treating infectious, allergic this drug to use by or on the order of a and traumatic keratitis and conjunc- licensed veterinarian. tivitis, acute otitis externa, and chron- [43 FR 40456, Sept. 12, 1978, as amended at 79 ic otitis externa. FR 10971, Feb. 27, 2014] (3) Limitations. Federal law restricts this drug to use by or on the order of a § 524.1484j Neomycin and prednisolone licensed veterinarian. ophthalmic ointment. [79 FR 10971, Feb. 27, 2014] (a) Specifications. Each gram of oint- ment contains prednisolone sodium § 524.1580 Nitrofurazone topical dos- phosphate equivalent to 2.5 milligrams age forms. prednisolone 21-phosphate and 5 milli- grams neomycin sulfate equivalent to § 524.1580a Nitrofurazone ointment. 3.5 milligrams neomycin base. (a) Specifications. The drug contains (b) Sponsor. See No. 000010 in 0.2 percent nitrofurazone in a water- § 510.600(c) of this chapter. soluble base. (c) Conditions of use in dogs and cats— (b) Sponsors. See sponsors in (1) Amount. A small quantity of the § 510.600(c) of this chapter. ointment should be expressed into the (1) See Nos. 054925, 058005, 059051, conjunctival sac 4 times a day (at in- 061133, and 069043 for use on dogs, cats, tervals of 1 to 8 hours) for a few days or horses. until there is a favorable response, (2) See No. 017135 for use on dogs and then the frequency of application may horses. be reduced to twice daily as long as the (3) See Nos. 017153 and 058829 for use condition remains under control. on horses. Treatment may require from a few (c) [Reserved] days to several weeks. (d) Conditions of use—(1) Amount. (2) Indications for use. For use in su- Apply directly on the lesion with a perficial ocular inflammations or infec- spatula or first place on a piece of tions limited to the conjunctiva or the gauze. The preparation should remain anterior segment of the eye, such as on the lesion for at least 24 hours. Use those associated with allergic reactions of a bandage is optional. or gross irritants. (2) Indications for use. For prevention (3) Limitations. Federal law restricts or treatment of surface bacterial infec- this drug to use by or on the order of a tions of wounds, burns, and cutaneous licensed veterinarian. ulcers of dogs, cats, or horses. [79 FR 10971, Feb. 27, 2014, as amended at 84 (3) Limitations. For use only on dogs, FR 39184, Aug. 9, 2019] cats, and horses. Do not use on horses intended for human consumption. Fed- § 524.1484k Neomycin and prednis- eral law prohibits the use of this prod- olone suspension. uct in food-producing animals. In case (a) Specifications. Each milliliter of of deep or puncture wounds or serious suspension contains 2.5 milligrams of burns, use only as recommended by and 5 milligrams veterinarian. If redness, irritation, or

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swelling persists or increases, dis- on the lesion for at least 24 hours. The continue use; consult veterinarian. dressing may be changed several times [46 FR 43402, June 27, 1980. Redesignated at 79 daily or left on the lesion for a longer FR 10971, Feb. 27, 2014] period. For use only on dogs, cats, and horses (not for food use). In case of EDITORIAL NOTE: For FEDERAL REGISTER ci- deep or puncture wounds or serious tations affecting § 524.1580a, see the List of CFR Sections Affected, which appears in the burns, use only as recommended by a Finding Aids section of the printed volume veterinarian. If redness, irritation, or and at www.govinfo.gov. swelling persists or increases, dis- continue use; consult veterinarian. § 524.1580b Nitrofurazone soluble pow- der. [49 FR 9417, Mar. 13, 1984, as amended at 71 FR 13542, Mar. 16, 2006. Redesignated at 79 FR (a) Specifications. The drug contains 10971, Feb. 27, 2014; 79 FR 10971, Feb. 27, 2014] 0.2 percent nitrofurazone in a water- soluble base. § 524.1600 Nystatin ophthalmic and (b) Sponsor. See Nos. 059051 and 069043 topical dosage forms. in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. § 524.1600a Nystatin, neomycin, Apply several times daily to the lesion thiostrepton, and triamcinolone or affected area from the plastic ointment. squeeze bottle. (a) Specifications. Each milliliter of (2) Indications for use. For prevention petrolatum base or each gram of van- or treatment of surface bacterial infec- ishing cream base ointment contains: tions of wounds, burns, skin ulcers, and 100,000 units of nystatin; neomycin sul- abscesses after incision. fate equivalent to 2.5 milligrams of ne- (3) Limitations. In case of deep or omycin base; 2,500 units of puncture wounds or serious burns, use thiostrepton; and 1.0 milligram of only as recommended by veterinarian. . If redness, irritation, or swelling per- sists or increases, discontinue use; con- (b) Sponsors. For petrolatum base sult veterinarian. For use only on dogs, ointments see Nos. 000856, 025463, 054771, cats, and horses (not for food use). and 054925 in § 510.600(c) of this chapter. For vanishing cream base ointments [45 FR 43402, June 27, 1980, as amended at 47 see Nos. 025463, 054771, and 054925. FR 43368, Oct. 1, 1982; 48 FR 28984, June 24, 1983; 53 FR 40728, Oct. 18, 1988; 54 FR 30542, (c) Conditions of use—(1) Amount. (i) July 21, 1989; 56 FR 50653, Oct. 8, 1991; 59 FR For topical dermatological use: Clean 33197, June 28, 1994; 60 FR 55659, Nov. 2, 1995; affected areas and remove any en- 62 FR 35077, June 30, 1997; 76 FR 17778, Mar. crusted discharge or exudate, and apply 31, 2011; 78 FR 21060, Apr. 9, 2013. Redesig- sparingly either ointment in a thin nated at 79 FR 10971, Feb. 27, 2014, as amend- film. ed at 79 FR 64117, Oct. 28, 2014; 83 FR 48947, Sept. 28, 2018] (ii) For otic use: Clean ear canal of impacted cerumen, remove any foreign § 524.1580c Nitrofurazone and buta- bodies such as grass awns and ticks, caine ointment. and instill three to five drops of petro- (a) Specifications. The drug contains latum base ointment. Preliminary use 0.2 percent nitrofurazone and 0.5 per- of a local anesthetic may be advisable. cent butacaine sulfate in a water-solu- (iii) For infected anal glands and cys- ble base. tic areas: Drain gland or cyst and fill (b) Sponsor. See No. 054925 in with petrolatum base ointment. § 510.600(c) of this chapter. (2) Indications for use. (i) Topically: (c) Conditions of use—(1) Indications Use either ointment in dogs and cats for use. For prevention or treatment of for anti-inflammatory, antipruritic, surface bacterial infections of ears, , and antibacterial treat- wounds, burns, and cutaneous ulcers of ment of superficial bacterial infec- dogs, cats, and horses. tions, and for dermatologic disorders (2) Limitations. Apply directly on the characterized by inflammation and dry lesion with a spatula or first place on a or exudative dermatitis, particularly piece of gauze. Use of a bandage is op- associated with bacterial or candidal tional. The preparation should remain (Candida albicans) infections.

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(ii) Otitis, cysts, and anal gland in- § 524.1610 Orbifloxacin, mometasone fections: Use petrolatum base ointment furoate monohydrate, and in dogs and cats for the treatment of posaconazole suspension. acute and chronic otitis and interdig- (a) Specifications. Each gram of sus- ital cysts, and in dogs for anal gland pension contains 10 milligrams (mg) infections. orbifloxacin, mometasone furoate (3) Limitations. Federal law restricts monohydrate equivalent to 1 mg this drug to use by or on the order of a mometasone furoate, and 1 mg licensed veterinarian. posaconazole. (b) Sponsor. See No. 000061 in [40 FR 13873, Mar. 27, 1975, as amended at 43 § 510.600(c) of this chapter. FR 29770, July 11, 1978; 50 FR 41490, Oct. 11, (c) Conditions of use in dogs—(1) 1985; 53 FR 39257, Oct. 6, 1988; 54 FR 5431, Feb. 3, 1989; 54 FR 48090, Nov. 21, 1989; 56 FR 50653, Amount. For dogs weighing less than 30 Oct. 8, 1991; 60 FR 55660, Nov. 2, 1995; 61 FR lbs. instill 4 drops once daily into the 63712, Dec. 2, 1996; 64 FR 42831, Aug. 6, 1999; 67 ear canal. For dogs weighing 30 lbs. or FR 67521, Nov. 6, 2002; 68 FR 55201, Sept. 23, more, instill 8 drops into the ear canal. 2003; 70 FR 50183, Aug. 26, 2005; 71 FR 13542, Therapy should continue for 7 consecu- Mar. 16, 2006; 79 FR 10972, Feb. 27, 2014] tive days. (2) Indications for use. For the treat- § 524.1600b Nystatin, neomycin, ment of otitis externa associated with thiostrepton, and triamcinolone susceptible strains of yeast (Malassezia ophthalmic ointment. pachydermatis) and bacteria (coagulase- (a) Specifications. Each cubic centi- positive staphylococci, Pseudomonas meter of ointment contains: 100,000 aeruginosa, and Enterococcus faecalis). units of nystatin, neomycin sulfate (3) Limitations. Federal law restricts equivalent to 2.5 milligrams of neomy- this drug to use by or on the order of a cin base, 2,500 units of thiostrepton, licensed veterinarian. and 1.0 milligram of triamcinolone [75 FR 16346, Apr. 1, 2010] acetonide. (b) Sponsor. See No. 053501 in § 524.1662 Oxytetracycline ophthalmic § 510.600(c) of this chapter. and topical dosage forms. (c) Related tolerances. See §§ 556.430 and 556.470 of this chapter. § 524.1662a Oxytetracycline and hydro- cortisone spray. (d) Conditions of use—(1) Dogs and cats—(i) Amount. Apply 1 drop of oint- (a) Specifications. Each 3-ounce unit ment to the affected eye(s) 2 or 3 times of oxytetracycline hydrochloride and daily. Treatment may be continued for hydrocortisone spray contains 300 mil- up to 2 weeks if necessary. ligrams of oxytetracycline hydro- (ii) Indications for use. For use as an chloride and 100 milligrams of hydro- anti-inflammatory, antipruritic, cortisone with an inert freon propel- antifungal (Candida albicans), and anti- lant such that a 1-second spray treat- bacterial ointment for local therapy in ment will deliver approximately 2.5 keratitis and conjunctivitis. milligrams of oxytetracycline hydro- (iii) Limitations. Federal law restricts chloride and 0.8 milligram of hydro- this drug to use by or on the order of a cortisone. licensed veterinarian. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (2) Cattle—(i) Amount. Apply small (c) Conditions of use in dogs and cats— line of ointment to the affected eye(s) (1) Amount. A small quantity should be once daily. Treatment may be contin- sprayed on the affected surface by ued for up to 2 weeks if necessary. holding the container about 6 inches (ii) Indications for use. For infectious from the area to be treated and press- kerato-conjunctivitis (pinkeye). ing the nozzle for 1 or 2 seconds. Only (iii) Limitations. Federal law restricts sufficient spray to coat the skin thinly this drug to use by or on the order of a is necessary. The application of small licensed veterinarian. amounts at frequent intervals will give [40 FR 13873, Mar. 27, 1975, as amended at 50 best results. Before treating animals FR 41490, Oct. 11, 1985; 79 FR 10972, Feb. 27, with long or matted hair, it may be 2014; 84 FR 32993, July 11, 2019] necessary to clip the affected area or

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spread the hairs to allow the medica- sitive bacteria or fungi appear during tion to contact the skin surface. Relief therapy, appropriate measures should may be noted following the first or sec- be taken. ond treatment; however, treatment [40 FR 13873, Mar. 27, 1975, as amended at 79 should not be discontinued too soon FR 10972, Feb. 27, 2014] after the initial favorable response has been obtained. § 524.1742 Phosmet emulsifiable liquid. (2) Indications for use. For the relief of (a) Specifications. The emulsifiable discomfort and continued treatment of liquid contains 11.6 percent N- many allergic, infectious, and trau- (mercaptomethyl) phthalimide S-(O,O- matic skin conditions; for the preven- dimethyl phosphorodithioate). tion of bacterial infections in super- (b) Sponsor. See No. 000061 in ficial wounds, cuts, and abrasions, § 510.600(c) of this chapter. treatment of allergic dermatoses, in- (c) Related tolerances. See 40 CFR cluding urticaria, eczemas, insect 180.261. bites, and cutaneous drug reactions, in- (d) Conditions of use—(1) Methods of fections associated with minor burns application. Methods of application to and wounds, and nonspecific pruritus. control the following conditions on (3) Limitations. Keep away from eyes beef cattle: or other mucous membranes; avoid in- haling; use with adequate ventilation; TABLE 1 TO PARAGRAPH (d)(1) in case of deep or puncture wounds or serious burns, consult a veterinarian. Dilution rate To control/method of use (gal. drug: gal. [40 FR 13873, Mar. 27, 1975, as amended at 79 of water) FR 10972, Feb. 27, 2014] Grubs: Dip ...... 1:60 § 524.1662b Oxytetracycline and poly- Pour-on ...... 1:2 myxin B ophthalmic ointment. Spray ...... 1:49 Lice: (a) Specifications. Each gram of the Dip ...... 1:60 ointment contains oxytetracycline hy- Pour-on ...... 1:2 or 1:5 Spray ...... 1:49 or 1:100 drochloride equivalent to 5 milligrams Hornflies: of oxytetracycline and 10,000 units of Dip ...... 1:60 polymyxin B sulfate. Spray ...... 1:49 or 1:100 Cattle Ticks: (b) Sponsor. See No. 054771 in Dip ...... 1:60 or 1:240 § 510.600(c) of this chapter. Spray ...... 1:49 (c) Conditions of use in dogs and cats— Southern cattle ticks: Dip ...... 1:60 or 1:240 (1) Amount. Administer topically to the Spray ...... 1:49 eye two to four times daily. Scabies mites:. (2) Indications for use. For the prophy- Dip ...... 1:60 laxis and local treatment of superficial Lone Star Ticks: Dip ...... 1:60 ocular infections due to Spray ...... 1:49 or 1:100 oxytetracycline- and polymyxin-sen- sitive organisms including ocular in- (i) Dip vat procedure. (A) Prior to fections due to streptococci, charging vat, empty old contents and rickettsiae, E. coli, and A. aerogenes thoroughly clean the vat. Dip vats (such as conjunctivitis, keratitis, pink- should be calibrated to maintain an ac- eye, corneal ulcer, and blepharitis in curate dilution. Add water, then drug dogs, cats, cattle, sheep, and horses); to the vat according to the dilution ocular infections due to secondary bac- rate indicated in the table. Add super terial complications associated with phosphate at a rate of 100 pounds per distemper in dogs; and ocular infec- 1,000 gallons of vat solution. Super tions due to bacterial inflammatory phosphate is added to control the pH of conditions which may occur secondary the solution and ensure vat stability. to other infectious diseases in dogs, Super phosphate is usually available at cats, cattle, sheep, and horses. most fertilizer dealers as 0–45–0 or 0–46– (3) Limitations. Allergic reactions 0. Stir the dip thoroughly, preferably may occasionally occur. Treatment with a compressed air device; however, should be discontinued if reactions are any form of thorough mixing is ade- severe. If new infections due to nonsen- quate. Re-stir vat contents prior to

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each use. During the dipping operation, gullet or spinal canal, as the rapid kill each time the dip’s volume is reduced of large numbers of larvae in these tis- by 1⁄8 to 1⁄4 of its initial volume, replen- sues may cause toxic side effects, such ish with water and add the drug at a as bloat, salivation, staggering, and pa- rate of 1 gallon for each 50 or 200 gal- ralysis. lons water added—depending on dilu- (3) Treatment regimens. (i) Control of tion rate 1:60 or 1:240. Also add super scabies mites requires two treatments, phosphate as necessary to maintain pH 10 to 14 days apart. between 4.5 and 6.5. Stir well and re- (ii) Control of Lone Star Ticks and sume dipping. Repeat replenishment hornflies requires two treatments, 7 process as necessary. For evaportion, days apart. add additional water accordingly. For (4) Warnings. The drug is a cholin- added water due to rainfall, merely re- esterase inhibitor. Do not use this drug plenish dip with the product according on animals simultaneously or within a to directions. If overflow occurs, either few days before or after treatment with analyze for drug concentration and ad- or exposure to cholinesterase-inhib- just accordingly or dispose of vat con- iting drugs, pesticides, or chemicals. tents and recharge. Check pH after Do not apply within 21 days of slaugh- each addition of water or super phos- ter. For use on beef cattle only. Do not phate to assure proper pH controls. treat sick, convalescent, or stressed (B) Dip maintenance. (1) With use of cattle, or calves less than 3 months old dip vat tester, dipping may continue as except in Federal or State eradication long as the drug concentration is main- programs where immediate treatment tained between 0.15 and 0.25 percent, of all animals in an infested herd is and the dip is not too foul for satisfac- mandatory. Be sure free access to tory use as indicated by foul odor or drinking water is available to cattle excessive darkening (i.e., color changes prior to dipping. Do not dip excessively from beige to very dark brown). thirsty animals. Do not dip animals (2) Without use of dip vat tester, vat when overheated. Repeat treatment as should be emptied, cleaned, and re- necessary but not more often than charged each time one of the following every 7 to 10 days. Treatment for lice, occurs: When the dip has been charged ticks, hornflies, and scabies mites may for 120 days; when the dip becomes too be made any time of the year except foul for satisfactory use, within the when cattle grub larvae are in the gul- 120-day limit; if the number of animals let or spinal canal. Treatment for lice, dipped equals twice the number of gal- ticks, and scabies mites may be made lons of the initial dip volume, within any time 7 to 10 days following treat- the 120-day limit. ment for grubs. Do not treat grubs (ii) Spray method. To prepare the when the grub larvae are in the gullet spray, mix drug with water according or spinal canal. Do not get in eyes, on to table and stir thoroughly. Apply the skin, or on clothing. Do not breathe fresh mixture as a high-pressure spray, spray mist. Wear rubber gloves, gog- taking care to wet the skin, not just gles, and protective clothing. In case of the hair. Apply to the point of ‘‘run- skin contact, wash immediately with off,’’ about 1 gallon of diluted spray per soap and water; for eyes, flush with adult animal. Lesser amounts will per- water. Wash all contaminated clothing mit runoff for younger animals. with soap and hot water before re-use. (iii) Pour-on method. Dilute the drug [40 FR 13873, Mar. 27, 1975, as amended at 46 with water according to table by slow- FR 27914, May 22, 1981; 48 FR 39607, Sept. 1, ly adding water to the product while 1983; 54 FR 51021, Dec. 12, 1989; 61 FR 8873, stirring. Apply 1 ounce of the diluted Mar. 6, 1996; 62 FR 61626, Nov. 19, 1997; 63 FR mixture per 100 pounds of body weight 5255, Feb. 2, 1998; 85 FR 18120, Apr. 1, 2020] (to a maximum of 8 ounces per head) down the center line of the back. § 524.1982 Proparacaine ophthalmic (2) Timing of applications for cattle solution. grub control. For optimum cattle grub (a) Specifications. The drug is an aque- control, it is important to treat as ous solution containing 0.5 percent soon as possible after the heel fly sea- proparacaine hydrochloride, 2.45 per- son, before the grub larvae reach the cent glycerin as a stabilizer, and 0.2

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percent chlorobutanol (choral deriva- eign bodies from the nose and ear tive) and 1:10,000 benzalkonium chlo- canal, as an accessory in the examina- ride as preservatives. tion and treatment of painful otitis, in (b) Sponsor. See No. 054771 in minor surgery, and prior to catheter- § 510.600(c) of this chapter. ization. (c) Conditions of use in dogs and cats— (2) It is administered as follows: (1) Amount. It is administered as fol- (i) For removal of sutures: Instill one lows: to two drops 2 or 3 minutes before re- (i) For removal of sutures: Instill one moval of stitches. to two drops 2 or 3 minutes before re- (ii) For removal of foreign bodies moval of stitches. from eye, ear, and nose: For oph- (ii) For removal of foreign bodies thalmic use, instill three to five drops from eye, ear, and nose: For oph- in the eye prior to examination; for thalmic use, instill three to five drops otic use, instill five to 10 drops in the in the eye prior to examination; for ear; for nasal use, instill five to 10 otic use, instill five to ten drops in the drops in each nostril every 3 minutes ear; for nasal use, instill five to ten for three doses. drops in each nostril every 3 minutes (iii) For tonometry: Instill one to for three doses. two drops immediately before measure- (iii) For tonometry: Instill one to ment. two drops immediately before measure- (iv) As an aid in treatment of otitis: ment. Instill two drops into the ear every 5 (iv) As an aid in treatment of otitis: minutes for three doses. Instill two drops into the ear every 5 (v) For minor surgery: Instill one or minutes for three doses. more drops as required. (v) For minor surgery: Instill one or (vi) For catheterization: Instill two more drops as required. to three drops with a blunt 20-gauge (vi) For catheterization: Instill two needle immediately before inserting to three drops with a blunt 20-gauge catheter. needle immediately before inserting (3) For use only by or on the order of catheter. a licensed veterinarian. (2) Indications for use. For use as a topical ophthalmic anesthetic. It is [40 FR 13873, Mar. 27, 1975, as amended at 50 used as an anesthetic in cauterization FR 41490, Oct. 11, 1985; 79 FR 10972, Feb. 27, of corneal ulcers, removal of foreign 2014] bodies and sutures from the cornea, § 524.2098 Selamectin. and measurement of intraocular pres- sure (tonometry) when glaucoma is (a) Specifications. Each milliliter con- suspected; as an aid in the removal of tains 60 or 120 milligrams of foreign bodies from the nose and ear selamectin. canal; as an accessory in the examina- (b) Sponsor. See Nos. 054771 and 055529 tion and treatment of painful otitis, in in § 510.600(c) of this chapter. minor surgery, and prior to catheter- (c) [Reserved] ization. (d) Conditions of use—(1) Amount. 2.7 (3) Limitations. Keep away from eyes milligrams of selamectin, topically, or other mucous membranes; avoid in- per pound (6 milligrams per kilogram) haling; use with adequate ventilation; of body weight. in case of deep or puncture wounds or (2) Indications for use. Kills adult fleas serious burns, consult a veterinarian. and prevents flea eggs from hatching (d) Conditions of use. (1) The drug is for 1 month, and it is indicated for the indicated for use as a topical oph- prevention and control of flea infesta- thalmic anesthetic in animals. It is tions (Ctenocephalides felis), prevention used as an anesthetic in cauterization of heartworm disease caused by of corneal ulcers, removal of foreign Dirofilaria immitis, and treatment and bodies and sutures from the cornea, control of ear mite (Otodectes cynotis) and measurement of intraocular pres- infestations in dogs and cats. Treat- sure (tonometry) when glaucoma is ment and control of sarcoptic mange suspected. Local applications may also (Sarcoptes scabiei) and control of tick be used as an aid in the removal of for- (Dermacentor variabilis) infestations in

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dogs. Treatment and control of intes- selenium disulfide (1-percent weight in tinal hookworm (Ancylostoma volume (w/v)). tubaeforme) and roundworm (Toxocara (b) Sponsors. See Nos. 000010, 000061, cati) infections in cats. For dogs 6 and 017135 in § 510.600(c) of this chapter. weeks of age and older, and cats 8 (c) Conditions of use on dogs—(1) Indi- weeks of age and older. cations for use. For use as a cleansing (3) Limitations. Federal law restricts and as an agent for removing this drug to use by or on the order of a skin debris associated with dry eczema, licensed veterinarian. seborrhea, and nonspecific dermatoses. (2) Amount. One to 2 ounces per appli- [64 FR 37401, July 12, 1999, as amended at 64 FR 48707, Sept. 8, 1999; 65 FR 45282, July 21, cation. 2000; 74 FR 19878, Apr. 30, 2009; 79 FR 10972, (3) Limitations. Use carefully around Feb. 27, 2014; 85 FR 18120, Apr. 1, 2020] scrotum and eyes, covering scrotum with petrolatum. Allow the shampoo to § 524.2099 Selamectin and sarolaner. remain for 5 to 15 minutes before thor- (a) Specifications. Each milliliter ough rinsing. Repeat treatment once or (mL) of solution contains 60 milligrams twice a week. If conditions persist or if (mg) selamectin and 10 mg sarolaner. rash or irritation develops, discontinue The drug is provided in single dose use and consult a veterinarian. tubes containing 0.25, 0.5, or 1 mL of so- [47 FR 53351, Nov. 26, 1982, as amended at 48 lution. FR 32762, July 19, 1983; 54 FR 36962, Sept. 6, (b) Sponsor. See No. 054771 in 1989; 56 FR 9623, Mar. 7, 1991; 58 FR 41025, § 510.600(c) of this chapter. Aug. 2, 1993; 63 FR 26981, May 15, 1998; 70 FR (c) Conditions of use in cats—(1) 50183, Aug. 26, 2005; 84 FR 39184, Aug. 9, 2019] Amount. Administer 2.7 mg selamectin § 524.2350 Tolnaftate cream. per pound (/lb) (6 mg per kilogram (/ kg)) of body weight and 0.45 mg/lb (a) Specifications. The drug contains 1 sarolaner (1 mg/kg) by emptying the percent tolnaftate in an anhydrous contents of the tube on the back of the cream base. animal at the base of the neck in front (b) Sponsor. See No. 000061 in of the shoulder blades. § 510.600(c) of this chapter. (2) Indications for use. For the preven- (c) Conditions of use—(1) Amount. tion of heartworm disease caused by Apply a small amount of the cream to Dirofilaria immitis. Kills adult fleas the affected areas once or twice a day (Ctenocephalides felis) and is indicated for 2 to 4 weeks. for the treatment and prevention of (2) Indications for use. For the treat- flea infestations; the treatment and ment of ringworm lesions due to control of tick infestations with Ixodes Microsporum canis and Microsporum scapularis (black-legged or deer tick), gypseum. Amblyomma maculatum (Gulf Coast (3) Limitations. Federal law restricts tick), and Dermacentor variabilis (Amer- this drug to use by or on the order of a ican dog tick); the treatment and con- licensed veterinarian. trol of ear mite (Otodectes cynotis) in- [79 FR 10972, Feb. 27, 2014] festations; and the treatment and con- trol of roundworm (Toxocara cati) and § 524.2482 Triamcinolone spray. intestinal hookworm (Ancylostoma (a) Specifications. Each milliliter of tubaeforme) infections in cats and kit- solution contains 0.15 milligrams tens 8 weeks of age and older, and triamcinolone acetonide. weighing 2.8 pounds or greater. (b) Sponsor. See No. 051311 in (3) Limitations. Federal law restricts § 510.600(c) of this chapter. this drug to use by or on the order of a (c) Conditions of use in dogs—(1) licensed veterinarian. Amount. Apply sufficient pump sprays [84 FR 12494, Apr. 2, 2019] to uniformly and thoroughly wet the affected areas while avoiding run off of § 524.2101 Selenium disulfide suspen- excess product. Administer twice daily sion. for 7 days, then once daily for 7 days, (a) Specifications. The product con- then every other day for an additional tains 0.9-percent weight in weight (w/w) 14 days (28 days total).

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(2) Indications for use. For the control PART 526—INTRAMAMMARY DOS- of pruritus associated with allergic der- AGE FORM NEW ANIMAL matitis. DRUGS (3) Limitations. Federal law restricts this drug to use by or on the order of a Sec. licensed veterinarian. 526.88 Amoxicillin trihydrate for intramammary infusion. [68 FR 4916, Jan. 31, 2003, as amended at 78 526.313 Ceftiofur. FR 17868, Mar. 25, 2013] 526.363 Cephapirin benzathine. 526.365 Cephapirin sodium. § 524.2483 Triamcinolone cream. 526.464 Cloxacillin intramammary dosage (a) Specifications. The vanishing forms. 526.464a Cloxacillin benzathine. cream contains 0.1 percent 526.464b Cloxacillin sodium for triamcinolone acetonide. intramammary infusion, sterile. (b) Sponsor. See Nos. 000010 and 054925 526.820 Erythromycin. in § 510.600(c) of this chapter. 526.1130 Hetacillin. (c) Conditions of use in dogs—(1) 526.1590 Novobiocin infusion. 526.1696 Penicillin intramammary dosage Amount. Rub into affected areas two to forms. four times daily for 4 to 10 days. 526.1696a Penicillin G procaine. (2) Indications for use. For topical 526.1696b Penicillin G procaine-dihydro- treatment of allergic dermatitis and streptomycin in soybean oil for summer eczema. intramammary infusion (dry cows). (3) Limitations. Federal law restricts 526.1696c Penicillin G procaine-dihydro- streptomycin sulfate for intramammary this drug to use by or on the order of a infusion (dry cows). licensed veterinarian. 526.1696d Penicillin G procaine-novobiocin for intramammary infusion. [71 FR 13542, Mar. 16, 2006, as amended at 73 526.1810 Pirlimycin. FR 79318, Dec. 29, 2008. Redesignated and amended at 75 FR 10168, Mar. 5, 2010; 77 FR AUTHORITY: 21 U.S.C. 360b. 60302, Oct. 3, 2012] § 526.88 Amoxicillin trihydrate for § 524.2620 Liquid crystalline trypsin, intramammary infusion. Peru balsam, castor oil. (a) Specifications. Each single dose sy- (a) Specifications. (1) Each gram of liq- ringe contains amoxicillin trihydrate uid or aerosol contains 0.12 milligram equivalent to 62.5 milligrams of of crystalline trypsin, 87.0 milligrams amoxicillin. (b) Sponsor. See No. 000061 in of Peru balsam, and 788.0 milligrams of § 510.600(c) of this chapter. castor oil. (c) Related tolerances. See § 556.38 of (2) Each gram of liquid or aerosol this chapter. contains 0.1 milligram of crystalline (d) Conditions of use—Lactating cows— trypsin, 72.5 milligrams of Peru bal- (1) Amount. One syringe (equivalent to sam, and 800 milligrams of castor oil. 62.5 milligrams amoxicillin) per quar- (b) Sponsors. See sponsor numbers in ter. § 510.600(c) of this chapter for use as in (2) Indications for use. For the treat- paragraph (c) in this section: ment of subclinical infectious bovine (1) No. 051079 for use of product de- mastitis due to Streptococcus agalactiae scribed in paragraph (a)(1). and Straphylococcus aureus (penicillin (2) No. 017135 for use of product de- sensitive). scribed in paragraph (a)(2). (3) Limitations. Administer after (c) Conditions of use—(1) Amount. milking. Clean and disinfect the teat. Apply directly to the wound site. Use one syringe per infected quarter (2) Indications for use. As an aid in the every 12 hours for a maximum of 3 treatment of external wounds and as- doses. Do not use milk taken from sists healing by facilitating the re- treated animals for food purposes with- moval of necrotic tissue, exudate, and in 60 hours (5 milkings) after last treat- ment. Do not slaughter treated ani- organic debris. mals for food purposes within 12 days [79 FR 10973, Feb. 27, 2014] after the last treatment. Federal law

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