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Food and Drug Administration, HHS Pt. 524

(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, , and poly- efficiency. myxin B ophthalmic ointment. (iii) Limitations. Implant 524.155 Bacitracin, neomycin, , subcutaneously in ear only. Safety and and ophthalmic oint- effectiveness have not been established ment. 524.390 ophthalmic oint- in veal calves. A withdrawal period has ment. not been established for this product in 524.402 . 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 . 138 mg zeranol (one implant consisting 524.660 Dimethyl sulfoxide. 524.770 Doramectin. of 7 pellets, each of 6 pellets containing 524.775 Emodepside and praziquantel. 20 mg zeranol and a seventh pellet con- 524.802 Enrofloxacin and silver taining 18 mg zeranol) per implant otic emulsion. dose. 524.814 Eprinomectin. (ii) Indications for use. For increased 524.900 Famphur. rate of weight gain. 524.920 Fenthion. (iii) Limitations. Implant 524.916 Fentanyl. 524.955 Florfenicol, , and subcutaneously in ear only. Safety and acetate otic gel. effectiveness have not been established 524.957 Florfenicol, terbinafine, and in veal calves. A withdrawal period has mometasone 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. calves to be processed for veal. 524.981 [Reserved] 524.981a Fluocinolone cream. [59 FR 19639, Apr. 25, 1994; 60 FR 26360, May 524.981b Fluocinolone solution. 17, 1995, as amended at 62 FR 61625, Nov. 19, 524.981c Fluocinolone and neomycin cream. 1997; 64 FR 46840, Aug. 27, 1999; 67 FR 6867, 524.981d Fluocinolone and dimethyl sulf- Feb. 14, 2002; 70 FR 6764, Feb. 9, 2005] oxide solution. 524.981e Fluocinolone and dimethyl sulf- § 522.2690 Zinc gluconate. oxide otic solution. 524.1005 powder. (a) Specifications. Each milliliter of 524.1044 sophthalmic and top- solution contains 13.1 milligrams zinc ical dosage forms. as zinc gluconate neutralized to pH 7.0 524.1044a Gentamicin ophthalmic solution. with L-arginine. 524.1044b Gentamicin and betamethasone (b) Sponsor. See No. 076175 in otic solution. § 510.600(c) of this chapter. 524.1044c Gentamicin ophthalmic ointment. 524.1044d Gentamicin and betamethasone (c) Conditions of use in dogs—(1) ointment. Amount. The volume injected into each 524.1044e Gentamicin spray. testicle is based on testicular width as 524.1044f Gentamicinand betamethasone determined by measuring each testicle spray. at its widest point using a metric scale 524.1044g Gentamicin, betamethasone, and (millimeter) caliper. clotrimazole ointment. 524.1044h Gentamicin, mometasone, and (2) Indications for use. Intratesticular clotrimazole otic suspension. injection for chemical sterilization of 524.1044i Gentamicin and betamethasone 3- to 10-month-old male dogs. ophthalmic solution. (3) Limitations. Federal law restricts 524.1132 Hydrocortisone, , and this drug to use by or on the order of a gentamicin otic suspension. licensed veterinarian. 524.1140 Imidacloprid and ivermectin. 524.1146 Imidacloprid and moxidectin. [68 FR 26995, May 19, 2003, as amended at 76 524.1193 Ivermectin topical solution. FR 79064, Dec. 21, 2011] 524.1195 Ivermectin otic suspension.

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

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(3) Limitations. Federal law restricts (b) Sponsors. See Nos. 054771 and this drug to use by or on the order of a 058829 in § 510.600(c) of this chapter. licensed veterinarian. (c) Conditions of use in dogs, cats, and horses—(1) Indications for use. For use [57 FR 37333, Aug. 18, 1992, as amended at 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, as a topical ointment for 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, surface wounds. Feb. 27, 2014; 80 FR 61297, Oct. 13, 2015] (2) Limitations. Do not use in horses intended for human consumption. § 524.155 Bacitracin, neomycin, poly- myxin B, and hydrocortisone oph- [72 FR 265, Jan. 4, 2007, as amended at 79 FR thalmic ointment. 10967, Feb. 27, 2014] (a) Specifications. Each gram of oint- § 524.450 Clotrimazole. ment contains 400 units of bacitracin zinc, 5 milligrams (mg) of neomycin (a) Specifications. Each gram of cream sulfate (equivalent to 3.5 mg of neomy- contains 10 milligrams of clotrimazole. cin sulfate), 10,000 units of polymyxin B (b) Sponsors. See No. 000859 in sulfate, and10 mg of hydrocortisone. § 510.600(c) of this chapter. (b) Sponsors. See Nos. 000061 and (c) Conditions of use—(1) Amount. 1 043264 in § 510.600(c) of this chapter. Apply ⁄4-inch ribbon of cream per (c) Conditions of use in dogs and cats— square inch of lesion once daily for 2 to (1) Amount. Apply a thin film over the 4 weeks. cornea three or four times daily. (2) Indications of use. For the treat- (2) Indications for use. For treating ment of fungal infections of dogs and acute or chronic conjunctivitis caused cats caused by Microsporum canis and by susceptible organisms. Trichophyton mentagrophytes. (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. [57 FR 37333, Aug. 18, 1992, as amended at 61 [40 FR 48128, July 18, 1980, as amended at 79 FR 8873, Mar. 6, 1996; 62 FR 61626, Nov. 19, FR 10967, Feb. 27, 2014] 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, Feb. 27, 2014] § 524.463 Copper naphthenate. (a) Amount. The drug is a 37.5 percent § 524.390 Chloramphenicol ophthalmic solution of copper naphthenate. ointment. (b) Sponsors. See Nos. 017135, 054771, (a) Specifications. Each gram contains and 058829 in § 510.600(c) of this chapter. 10 milligrams chloramphenicol. (c) Conditions of use in horses—(1) (b) Sponsors. See Nos. 043264 and Amount. Apply daily to affected hooves 054771 in § 510.600(c) of this chapter. until fully healed. (c) Conditions of use in dogs and cats— (2) Indications for use. As an aid in (1) Amount. Apply every 3 hours around treating horses and ponies for thrush the clock for 48 hours, after which caused by organisms susceptible to night instillations may be omitted. copper naphthenate. (2) Indications for use. For treatment (3) Limitations. Use on horses and of bacterial conjunctivitis caused by ponies only. Avoid contact around pathogens susceptible to chloramphen- eyes. Do not contaminate feed. Do not icol. use in horses intended for human con- (3) Limitations. Federal law restricts sumption. this drug to use by or on the order of a licensed veterinarian. Federal law pro- [47 FR 4250, Jan. 29, 1982, as amended at 68 FR 55825, Sept. 29, 2003; 71 FR 38074, July 5, hibits the use of this drug in food-pro- 2006; 79 FR 10967, Feb. 27, 2014] ducing animals. [77 FR 4897, Feb. 1, 2012, as amended at 77 FR § 524.575 Cyclosporine ophthalmic 64717, Oct. 23, 2012; 79 FR 10967, Feb. 27, 2014] ointment. (a) Specifications. Each gram of oint- § 524.402 Chlorhexidine. ment contains 2 milligrams of (a) Specifications. Each gram of oint- cyclosporine. ment contains 10 milligrams (b) Sponsor. See No. 000061 in chlorhexidine acetate. § 510.600(c) of this chapter.

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(c) Conditions of use—(1) Amount. (ii) Dogs. Apply topically three to Apply a 1⁄4-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 [79 FR 10967, Feb. 27, 2014] licensed veterinarian. § 524.770 Doramectin. [60 FR 48651, Sept. 20, 1995, as amended at 62 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 § 556.225 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 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), Cooperia intended for human consumption. Fed- oncophora (adults and fourth-stage lar- eral law restricts this drug to use by or vae), Cooperia punctata (adults and on the order of a licensed veterinarian. 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 (b) Sponsor. See No. 054771 in Solenopotes capillatus; biting lice: § 510.600(c) of this chapter. Bovicola (Damalinia) bovis; mange (c) Conditions of use in horses and mites: Chorioptes bovis and Sarcoptes dogs—(1) Amount—(i) Horses. Apply scabiei; horn flies: Haematobia irritans; topically two to three times daily in an and to control infections and to protect amount not to exceed 100 mL per day. from reinfection with Cooperia Total duration of therapy should not oncophora, Dictyocaulus viviparus, exceed 30 days. Ostertagia ostertagi, and

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Oesophagostomum radiatum for 28 days; (c) Conditions of use—Dogs—(1) and with Cooperia punctata and Amount. 5 to 10 drops for dogs weighing Haemonchus placei for 35 days after 35 pounds (lb) or less and 10 to 15 drops treatment; and to control infestations for dogs weighing more than 35 lb; ap- and to protect from reinfestation with plied twice daily for up to 14 days. Linognathus vituli for 42 days and with (2) Indications for use. For the treat- Bovicola (Damalinia) bovis for 77 days ment of otitis externa in dogs. after treatment. (3) Limitations. Federal law restricts (3) Limitations. Do not slaughter cat- this drug to use by or on the order of a tle within 45 days of latest treatment. licensed veterinarian. Federal law pro- This product is not approved for use in hibits the extralabel use of this drug in female dairy cattle 20 months of age or food-producing animals. older, including dry dairy cows. Use in [65 FR 66620, Nov. 7, 2000, as amended at 79 these cattle may cause drug residues in FR 10967, Feb. 27, 2014] milk and/or in calves born to these cows. A withdrawal period has not been § 524.814 Eprinomectin. established for this product in (a) Specifications. Each milliliter preruminating calves. Do not use in (mL) contains 5 milligrams (mg) of calves to be processed for veal. eprinomectin. [69 FR 48392, Aug. 10, 2004, as amended at 70 (b) Sponsor. See No. 050604 in FR 43046, July 26, 2005; 79 FR 10967, Feb. 27, § 510.600(c) of this chapter. 2014] (c) Related tolerances. See § 556.227 of this chapter. § 524.775 Emodepside and (d) Special considerations. See § 500.25 praziquantel. of this chapter. (a) Specifications. Each milliliter of (e) Conditions of use in cattle—(1) solution contains 21.4 milligrams (mg) Amount. Apply 5 mg (1 mL) per 10 kilo- emodepside and 85.7 mg praziquantel. grams (kg) of body weight (500 (b) Sponsor. See No. 000859 in micrograms/kg) applied topically along § 510.600(c) of this chapter. backbone from withers to tailhead. (c) Conditions of use in cats—(1) (2) Indications for use. For treatment Amount. The recommended minimum and control of gastrointestinal dose is 1.36 mg/pound (lb) (3 mg/kilo- roundworms (Haemonchus placei (adult gram (kg)) emodepside and 5.45 mg/lb and L4), Ostertagia ostertagi (adult and (12 mg/kg) praziquantel applied as a L4, including inhibited L4), single topical dose. Trichostrongylus axei (adult and L4), T. (2) Indications for use. For the treat- colubriformis (adult and L4), T. ment and control of hookworm infec- longispicularis (adult), Cooperia tions caused by Ancylostoma tubaeforme oncophora (adult and L4), C. punctata (adults, immature adults, and fourth (adult and L4), C. surnabada (adult and stage larvae), roundworm infections L4), Nematodirus helvetianus (adult and caused by Toxocara cati (adults and L4), Bunostomum phlebotomum (adult fourth stage larvae), and tapeworm in- and L4), Oesophagostomum radiatum fections caused by Dipylidium caninum (adult and L4), Strongyloides papillosus (adults) and Taenia taeniaeformis (adults), Trichuris spp. (adults)); (adults). lungworms (Dictyocaulus viviparus, adult and L4); cattle grubs (all para- (3) Limitations. Federal law restricts sitic stages this drug to use by or on the order of a Hypoderma lineatum, H. ); lice ( licensed veterinarian. bovis Damalinia bovis, Linognathus vituli, Haematopinus [72 FR 42291, Aug. 2, 2007] eurysternus, Solenopotes capillatus); mange mites (Chorioptes bovis, Sarcoptes § 524.802 Enrofloxacin and silver sulfa- scabiei); and horn flies (Haematobia diazine otic emulsion. irritans). Controls and protects from re- (a) Specifications. Each milliliter con- of D. viviparus for 21 days tains 5 milligrams (mg) enrofloxacin after treatment and H. irritans for 7 and 10 mg silver sulfadiazine. days after treatment. (b) Sponsor. See No. 000859 in (3) Limitations. A withdrawal period § 510.600(c) of this chapter. has not been established for

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preruminating calves. Do not use in (ii) Indications for use. For the control calves to be processed for veal. of postoperative pain associated with surgical procedures in dogs. [76 FR 72619, Nov. 25, 2011] (iii) Limitations. Fentanyl is a Class II § 524.900 Famphur. controlled substance. Observe all ‘‘black-box warnings’’ on product label- (a) Specifications. The drug is in liquid ing. Federal law restricts this drug to form containing 13.2 percent famphur. use by or on the order of a licensed vet- (b) Sponsor. See Nos. 000061 and 051311 erinarian. in § 510.600(c) of this chapter. (2) [Reserved] (c) Special considerations. Do not use on animals simultaneously or within a [77 FR 47512, Aug. 9, 2012, as amended at 79 few days before or after treatment with FR 44433, July 24, 2013] or exposure to cholinesterase-inhib- iting drugs, pesticides, or chemicals. § 524.920 Fenthion. (d) Related tolerances. See § 556.273 of (a) Specifications. (1) The drug is a liq- this chapter. uid containing: (e) Conditions of use—(1) Amount. (i) 3 percent of fenthion; or Apply 1 ounce per 200 pounds body (ii) 20 percent fenthion. weight, not to exceed a total dosage of (2) The drug is a solution containing 4 ounces, from the shoulder to the tail either 5.6 or 13.8 percent fenthion. Each head as a single treatment. Apply as concentration is available in 2 volumes soon as possible after heel fly activity which are contained in single-dose ap- ceases. plicators. (2) Indications for use in beef and non- (b) Sponsor. See sponsors in lactating dairy cattle. For control of cat- § 510.600(c) of this chapter: tle grubs and to reduce cattle lice in- (1) No. 000859 for use of product de- festations. scribed in paragraph (a)(1)(i) as in para- (3) Limitations. Do not slaughter with- graph (d)(1) of this section. in 35 days after treatment. Do not use (2) No. 000859 for use of product de- on lactating dairy cows or dry dairy scribed in paragraph (a)(1)(ii) as in cows within 21 days of freshening, paragraph (d)(2) of this section. calves less than 3 months old, animals (3) No. 000859 for use of products de- stressed from castration, overexcite- scribed in paragraph (a)(2) as in para- ment or dehorning, sick or convales- graph (d)(3) of this section. cent animals. Animals may become de- (c) Related tolerances. See 40 CFR hydrated and under stress following 180.214. shipment. Do not treat until they are (d) Conditions of use—(1) Beef cattle in good condition. Brahman and Brah- and nonlactating dairy cattle—(i) man crossbreeds are less tolerant of Amount. It is used at the rate of one- cholinesterase-inhibiting insecticides half fluid ounce per 100 pounds of body than other breeds. Do not treat Brah- weight applied topically on the man bulls. Swine should be eliminated backline of the animal. Only one appli- from area where runoff occurs. cation per season should be made for [40 FR 13873, Mar. 27, 1975, as amended at 49 grub control and this will also provide FR 34352, Aug. 30, 1984; 57 FR 7652, Mar. 4, initial control of lice. A second appli- 1992; 59 FR 28769, June 3, 1994; 62 FR 55161, cation for lice control may be made if Oct. 23, 1997; 62 FR 61626, Nov. 19, 1997; 69 FR animals become reinfested, but no 41427, July 9, 2004; 79 FR 10968, Feb. 27, 2014] sooner than 35 days after the first treatment. Proper timing of treatment § 524.916 Fentanyl. is important for grub control; cattle (a) Specifications. Each milliliter of should be treated as soon as possible solution contains 50 milligrams (mg) after heel-fly activity ceases. fentanyl. (ii) Indications for use. For the control (b) Sponsor. See No. 000986 in of grubs and lice in beef and nonlac- § 510.600(c) of this chapter. tating cattle. (c) Conditions of use—(1) Dogs—(i) (iii) Limitations. Do not use on ani- Amount. 1.2 mg/lb (2.7 mg/kg) applied mals simultaneously or within a few topically to the dorsal scapular area 2 days before or after treatment with or to 4 hours prior to surgery. exposure to cholinesterase-inhibiting

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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 dog’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 [79 FR 10968, Feb. 27, 2014] pounds, apply 20 mL. For most effec- tive results, cattle should be treated as § 524.955 Florfenicol, terbinafine, and soon as possible after heel-fly activity betamethasone acetate otic gel. ceases. A second application is required (a) Specifications. Each milliliter of for animals heavily infested with lice gel contains 10 milligrams (mg) or for those which become reinfested. A florfenicol, 10 mg terbinafine, and 1 mg second application should be made no betamethasone acetate. sooner than 35 days after the first (b) Sponsor. See No. 058198 in treatment. § 510.600(c) of this chapter. (ii) Indications for use. For control of (c) Conditions of use in dogs—(1) cattle grubs and as an aid in control- Amount. Administer one dose (1 tube) ling lice on beef cattle and on dairy per affected ear(s) and repeat adminis- cattle not of breeding age. tration in 7 days. (iii) Limitations. Do not use on ani- (2) Indications for use. For the treat- mals simultaneously or within a few ment of otitis externa in dogs associ- days before or after treatment with or ated with susceptible strains of bac- exposure to cholinesterase-inhibiting teria (Staphylococcus pseudintermedius) drugs, pesticides, or chemicals. Host- and yeast ( pachydermatis). parasite reactions such as bloat, saliva- tion, staggering and paralysis may (3) Limitations. Federal law restricts sometimes occur when cattle are treat- this drug to use by or on the order of a ed while the common cattle grub licensed veterinarian. (Hypoderma lineatum) is in the gullet, [80 FR 13230, Mar. 13, 2015] or while the northern cattle grub (H. bovis) is in the area of the spinal cord. § 524.957 Florfenicol, terbinafine, and Cattle should be treated before these mometasone otic solution. stages of grub development. Consult (a) Specifications. Each single-dose, your veterinarian, extension livestock prefilled dropperette contains 1 milli- specialist, or extension entomologist liter (mL) of a solution containing 15 regarding the timing of treatment. If it milligrams (mg) florfenicol, 13.3 mg

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terbinafine, and 2 mg mometasone (c) Conditions of use in dogs—(1) furoate. Amount—A small amount is applied to (b) Sponsor. See No. 000859 in the affected area two or three times § 510.600(c) of this chapter. daily. (c) Conditions of use in dogs—(1) (2) Indications for use. For the relief of Amount. Administer one dropperette (1 pruritis and inflammation associated mL) per affected ear(s). with certain superficial acute and (2) Indications for use. For the treat- chronic dermatoses. It is used in the ment of otitis externa in dogs associ- treatment of allergic and acute moist ated with susceptible strains of yeast and for the relief of super- (Malassezia pachydermatis) and bacteria ficial inflammation caused by chemical (Staphylococcus pseudintermedius). and physical abrasions. (3) Limitations. Federal law restricts (3) Federal law restricts this drug to this drug to use by or on the order of a use by or on the order of a licensed vet- licensed veterinarian. erinarian. [80 FR 76387, Dec. 9, 2015] [40 FR 13873, Mar. 27, 1975, as amended at 62 FR 40932, July 31, 1997; 79 FR 10968, Feb. 27, § 524.960 Flumethasone, neomycin, 2014] and polymyxin B ophthalmic solu- tion. § 524.981b Fluocinolone solution. (a) Specifications. Each milliliter of (a) Specifications. The drug contains ophthalmic preparation contains 0.10 0.01 percent . milligram flumethasone, 5.0 milligrams (b) Sponsor. See No. 099207 in neomycin sulfate (3.5 milligrams neo- § 510.600(c) of this chapter. mycin base), and 10,000 units of poly- (c) Conditions of use in dogs—(1) myxin B sulfate, with or without Amount—A small amount of solution is hydroxypropyl methylcellulose. applied to the affected area two or (b) Sponsor. See No. 054771 in three times daily. § 510.600(c) of this chapter. (2) Indications for use—(i) Dogs. For (c) Conditions of use—(1) Amount—(i) the relief of pruritis and inflammation Preparation containing hydroxypropyl associated with otitis externa and cer- methylcellulose. Dogs: 1 to 2 drops per tain superficial acute and chronic eye, every 6 hours. dermatoses. (ii) Preparation without hydroxyproply (ii) Cats. For the relief of pruritis and methylcellulose. Dogs and cats: 2 to 3 inflammation associated with acute drops per eye, every 4 hours. otitis externa and certain superficial (2) Indications for use. Treatment of acute and chronic dermatoses. the inflammation, edema, and sec- (3) Federal law restricts this drug to ondary bacterial infections associated use by or on the order of a licensed vet- with topical ophthalmological condi- erinarian. tions of the eye such as corneal inju- [40 FR 13873, Mar. 27, 1975, as amended at 62 ries, incipient pannus, superficial kera- FR 40932, July 31, 1997; 79 FR 10969, Feb. 27, titis, conjunctivitis, acute 2014] nongranulomatous anterior uveitis, kerato- conjunctivitis, and blepharitis. § 524.981c Fluocinolone and neomycin (3) Limitations. Federal law restricts cream. this drug to use by or on the order of a (a) Specifications. The drug contains licensed veterinarian. 0.025 percent fluocinolone acetonide [44 FR 16012, Mar. 16, 1979, as amended at 61 and 0.5 percent neomycin sulfate (0.35 FR 5507, Feb. 13, 1996; 79 FR 10968, Feb. 27, percent neomycin base). 2013] (b) Sponsor. See No. 099207 in § 510.600(c) of this chapter. § 524.981 [Reserved] (c) Conditions of use in dogs—(1) Amount—A small amount is applied to § 524.981a Fluocinolone cream. the affected area two or three times (a) Specifications. The drug contains daily. 0.025 percent fluocinolone acetonide. (2) Indications for use—(i) Dogs. For (b) Sponsor. See No. 099207 in the relief of pruritis and inflammation § 510.600(c) of this chapter. associated with superficial acute and

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chronic dermatoses. It is used in the § 524.1005 Furazolidone powder. treatment of allergic and acute moist (a) Specifications. The product con- dermatitis and nonspecific dermatoses. tains either 4 or 10 percent furazolidone (ii) Dogs and cats. Used in the treat- ment of wound infections. in inert dispersing agent and propel- lant. (3) Federal law restricts this drug to use by or on the order of a licensed vet- (b) Sponsors. (1) See No. 054771 in erinarian. § 510.600(c) of this chapter for use as in paragraphs (c)(1), (c)(2)(i), (c)(2)(ii), and [40 FR 13873, Mar. 27, 1975, as amended at 62 (c)(3) of this section. FR 40932, July 31, 1997; 79 FR 10969, Feb. 27, (2) See No. 017135 for use of the 4 per- 2014] cent product as in paragraph (c)(2)(iv) § 524.981d Fluocinolone and dimethyl of this section. sulfoxide solution. (c) Conditions of use—(1) Amount. Hold (a) Specifications. Each milliliter of container about 6 to 12 inches from the solution contains 0.01 percent eye or affected area and apply only fluocinolone acetonide and 20 percent enough powder to impart a light yellow dimethyl sulfoxide. color. (b) Sponsor. See No. 054771 in (2) Indications of use—(i) Dogs. For § 510.600(c) of this chapter. treatment or prevention of bacterial (c) Conditions of use in dogs—(1) infection of superficial wounds, abra- Amount—Instill 1 to 2 milliliters into sions, lacerations, and pyogenic derma- each anal sac following expression of titis. anal sac contents. (ii) Horses. For treatment or preven- (2) Indications for use. For the relief of tion of bacterial infection of superficial impaction commonly present in appar- wounds, abrasions, lacerations, and fol- ently normal anal sacs, for the reversal lowing firing (heat or electrocautery). of inflammatory changes associated (iii) [Reserved] with abnormal anal sacs, and to coun- (iv) Horses and ponies. For treatment teract the offensive odor of anal sac se- or prevention of bacterial infection of cretions. superficial wounds, abrasions, and lac- (3) Limitations. Federal law restricts erations caused by Staphylococcus this drug to use by or on the order of a aureus, Streptococcus spp. and Proteus licensed veterinarian. spp. sensitive to furazolidone. [79 FR 10969, Feb. 27, 2014] (3) Limitations. For topical applica- tion in horses, ponies, and dogs: Clean § 524.981e Fluocinolone and dimethyl affected area thoroughly, apply drug sulfoxide otic solution. once or twice daily, and repeat treat- (a) Specifications. Each milliliter of ment as required. Use only as rec- solution contains 0.01 percent ommended by a veterinarian in treat- fluocinolone acetonide and 60 percent ment of puncture wounds, wounds re- dimethyl sulfoxide. quiring surgical debridement or sutur- (b) Sponsor. See No. 054771 in ing, those of a chronic nature involving § 510.600(c) of this chapter. proud flesh, generalized and chronic in- (c) Conditions of use in dogs—(1) fections of the skin, and those skin Amount—Instill 4 to 6 drops (0.2 milli- conditions associated with intense liter) twice daily into the ear canal for itching. If redness, irritation, or swell- a maximum period of 14 days. The total ing persists or increases, discontinue dosage used should not exceed 17 milli- use and consult a veterinarian. Do not liters. use in horses intended for human con- (2) Indications for use. For the relief of pruritis and inflammation associated sumption. with acute and chronic otitis. [45 FR 49543, July 25, 1980, as amended at 50 (3) Limitations. Federal law restricts FR 30153, July 24, 1985; 56 FR 50653, Oct. 8, this drug to use by or on the order of a 1991; 57 FR 31314, July 15, 1992; 60 FR 55659, licensed veterinarian. Nov. 2, 1995; 65 FR 41588, July 6, 2000; 79 FR 10969, Feb. 27, 2014] [79 FR 10969, Feb. 27, 2014]

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§ 524.1044 Gentamicin ophthalmic and (b) Sponsors. See Nos. 000061 and topical dosage forms. 043264 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— § 524.1044a Gentamicin ophthalmic so- (1) Amount. Apply approximately a 1/2- lution. inch strip to the affected eye 2 to 4 (a) Specifications. Each milliliter of times a day. solution contains gentamicin sulfate (2) Indications for use. For treatment equivalent to 3 milligrams of of conjunctivitis caused by susceptible gentamicin. bacteria. (b) Sponsors. See Nos. 000061 and (3) Limitations. Federal law restricts 059399 in § 510.600(c) of this chapter. this drug to use by or on the order of a licensed veterinarian. (c) Conditions of use in dogs and cats— (1) Amount. Administer 1 or 2 drops into [69 FR 47363, Aug. 5, 2004, as amended at 77 the conjunctival sac 2 to 4 times a day. FR 64717, Oct. 23, 2012] (2) Indications for use. For the topical treatment of infections of the con- § 524.1044d Gentamicin and betamethasone ointment. junctiva caused by susceptible bac- teria. (a) Specifications. Each gram of oint- (3) Limitations. Federal law restricts ment contains gentamicin sulfate this drug to use by or on the order of a equivalent to 3 milligrams of licensed veterinarian. gentamicin base and betamethasone valerate equivalent to 1 milligram of [80 FR 18776, Apr. 8, 2015] betamethasone. (b) Sponsor. See No. 000061 in § 524.1044b Gentamicin and § 510.600(c) of this chapter. betamethasone otic solution. (c) Conditions of use in dogs—(1) (a) Specifications. Each milliliter of Amount—(i) Otitis externa. Instill 3 to 8 solution contains gentamicin sulfate drops into the ear canal twice daily for equivalent to 3 milligrams (mg) 7 days. gentamicin base and betamethasone (ii) Infected superficial lesions. Apply valerate equivalent to 1 mg to cover the treatment area twice daily betamethasone alcohol. for 7 to 14 days. (b) Sponsors. See Nos. 000061 and (2) Indications for use. For the treat- 054925 in § 510.600(c) of this chapter. ment of acute and chronic otitis (c) Conditions of use—(1) Amounts and externa and infected superficial lesions indications for use—(i) For the treat- caused by bacteria sensitive to ment of acute and chronic otitis gentamicin. externa caused by bacteria sensitive to (3) Limitations. Federal law restricts gentamicin in dogs, instill three to this drug to use by or on the order of a eight drops of solution into the ear licensed veterinarian. canal twice daily for 7 to 14 days. [47 FR 26378, June 18, 1982, as amended at 52 (ii) For the treatment of infected su- FR 7832, Mar. 13, 1987; 79 FR 10969, Feb. 27, perficial lesions caused by bacteria 2014] sensitive to gentamicin in dogs and § 524.1044e Gentamicin spray. cats, apply a sufficient amount of the drug to cover the treatment area twice (a) Specification. Each milliliter of daily for 7 to 14 days. sterile aqueous solution contains (2) Limitations. Federal law restricts gentamicin sulfate equivalent to 1.07 this drug to use by or on the order of a milligrams of gentamicin. licensed veterinarian. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. [71 FR 13542, Mar. 16, 2006] (c) Conditions of use in cattle—(1) Amount. Hold the sprayer upright 3 to 6 § 524.1044c Gentamicin ophthalmic inches from the affected eye, with the ointment. opening directed towards the eye, and (a) Specifications. Each gram of oint- pump once. Treat once daily for up to ment contains gentamicin sulfate 3 days. equivalent to 3 milligrams of (2) Indications for use. For the treat- gentamicin. ment of pinkeye in cattle (infectious

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bovine keratoconjunctivitis) caused by (4) No. 025463 for use of 7.5- or 15-g Moraxella bovis. tubes, or 215-g bottles. (3) Limitations. Conditions other than (c) Conditions of use in dogs—(1) bacterial infections of the bovine eye Amount. Instill ointment twice daily and infectious keratoconjunctivitis into the ear canal for 7 consecutive caused by Moraxella bovis may produce days. similar signs. If conditions persists or (i) From 7.5- or 15-g tubes; 10-, 12.5-, increases, discontinue use and consult 15-, 25-, or 30-g bottles: 4 drops for dogs a veterinarian. weighing less than 30 pounds (lb) or 8 drops for dogs weighing 30 lb or more. [48 FR 41157, Sept. 14, 1983, as amended 52 FR 7833, Mar. 13, 1987; 79 FR 10969, Feb. 27, 2014] (ii) From 20-, 40-, or 215-g bottles: 2 drops for dogs weighing less than 30 lb § 524.1044f Gentamicin and or 4 drops for dogs weighing 30 lb or betamethasone spray. more. (a) Specifications. Each milliliter of (ii) From 20- or 215-g bottles: 2 drops spray contains gentamicin sulfate for dogs weighing less than 30 lb or 4 equivalent to 0.57 milligram (mg) drops for dogs weighing 30 lb or more. gentamicin base and betamethasone (2) Indications for use. For the treat- valerate equivalent to 0.284 mg ment of acute and chronic canine otitis betamethasone. externa associated with yeast (b) Sponsors. See Nos. 000061, 054925, (Malassezia pachydermatis, formerly 058005, 058829, and 065531 in § 510.600(c) of Pityrosporum canis) and/or bacteria sus- this chapter. ceptible to gentamicin. (c) Conditions of use in dogs—(1) (3) Limitations. Federal law restricts Amount. Hold bottle upright 3 to 6 this drug to use by or on the order of a inches from the lesion and depress the licensed veterinarian. sprayer head twice. Administer two [58 FR 38973, July 21, 1993, as amended at 63 spray actuations two to four times FR 31932, June 11, 1998; 68 FR 42970, July 21, daily for 7 days. 2003; 70 FR 8291, Feb. 18, 2005; 71 FR 13542, (2) Indications for use. For the treat- Mar. 16, 2006; 71 FR 16481, Apr. 3, 2006; 71 FR 38261, July 6, 2006; 71 FR 56867, Sept. 28, 2006; ment of infected superficial lesions 78 FR 17597, Mar. 22, 2013; 79 FR 10969, Feb. 27, caused by bacteria susceptible to 2014; 81 FR 17608, Mar. 30, 2016] gentamicin. (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 contains [71 FR 13542, Mar. 16, 2006, as amended at 72 gentamicin sulfate, United States FR 5929, Feb. 8, 2007; 74 FR 22822, May 15, Pharmacopeia (USP) equivalent to 3 2009; 77 FR 3598, Jan. 25, 2012] milligram (mg) gentamicin base, mometasone furoate monohydrate § 524.1044g Gentamicin, equivalent to 1 mg mometasone, and 10 betamethasone, and clotrimazole mg clotrimazole, USP. ointment. (b) Sponsor. See No. 000061 in (a) Specifications. Each gram (g) of § 510.600(c) of this chapter. ointment contains gentamicin sulfate (c) Conditions of use in dogs—(1) equivalent to 3 milligrams (mg) Amount. For dogs weighing less than 30 gentamicin base, betamethasone val- pounds (lb), instill 4 drops from the 7.5- erate equivalent to 1 mg , 15-, or 30-gram (g) bottle into the ear betamethasone, and 10 mg canal (2 drops from the 215-g bottle) or, clotrimazole. for dogs weighing 30 lb or more, instill (b) Sponsors. See sponsors in 8 drops from the 7.5-, 15-, or 30-g bottle § 510.600(c) of this chapter for uses as in into the ear canal (4 drops from the 215- paragraph (c) of this section. g bottle), once or twice daily for 7 days. (1) No. 000061 for use of 7.5- or 15-gram (2) Indications for use. For the treat- (g) tubes, 12.5-, 30-, or 215-g bottles. ment of otitis externa caused by sus- (2) No. 054925 for use of 7.5- or 15-g ceptible strains of yeast (Malassezia tubes; 10-, 15-, 25-, or 215-g bottles. pachydermatis) and bacteria (3) No. 069043 for use of 10-, 20-, 40-, or (Pseudomonas spp. [including P. 215-g bottles. aeruginosa], coagulase-positive

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staphylococci, Enterococcus faecalis, § 524.1140 Imidacloprid and Proteus mirabilis, and beta-hemolytic ivermectin. streptococci). (a) Specifications. The product is (3) Limitations. Federal law restricts available in unit applicator tubes con- this drug to use by or on the order of a taining 0.4, 1.0, 2.5, or 4.0 milliliters licensed veterinarian. (mL). Each mL of solution contains 100 milligrams (mg) imidacloprid and 800 [66 FR 712, Jan. 4, 2001, as amended at 68 FR micrograms (μg) ivermectin. 15370, Mar. 31, 2003; 70 FR 36338, June 23, 2005; (b) Sponsor. See No. 000859 in 79 FR 10969, Feb. 27, 2014] § 510.600(c) of this chapter. § 524.1044i Gentamicin and (c) Conditions of Use in Dogs—(1) betamethasone ophthalmic solution. Amount. The recommended minimum dosage is 4.5 mg/pound (lb) (10 mg/kilo- (a) Specifications. Each milliliter gram (kg)) of imidacloprid and 36.4 μg/ (mL) of solution contains gentamicin lb (80 μg/kg) of ivermectin, topically sulfate equivalent to 3 milligrams (mg) once a month. of gentamicin base and 1 mg (2) Indications for Use. For the preven- betamethasone acetate equivalent to tion of heartworm disease caused by 0.89 mg betamethasone alcohol. Dirofilaria immitis; kills adult fleas and (b) Sponsor. See No. 000061 in is indicated for the treatment of flea § 510.600(c) of this chapter. infestations (Ctenocephalides felis). (c) Conditions of use in dogs—(1) (3) Limitations. Federal law restricts Amount. Instill one or two drops of so- this drug to use by or on the order of a lution in the conjunctival sac three or licensed veterinarian. four times a day. [67 FR 78685, Dec. 26, 2002] (2) Indications for use. For treatment of external eye infections and inflam- § 524.1146 Imidacloprid and moxidectin. mation. (3) Limitations. Federal law restricts (a) Specifications—(1) Each milliliter this drug to use by or on the order of a of solution contains 100 milligrams (mg) imidacloprid and 25 mg licensed veterinarian. moxidectin for use as in paragraph [75 FR 54492, Sept. 8, 2010, as amended at 80 (d)(1) of this section. FR 13230, Mar. 13, 2015] (2) Each milliliter of solution con- tains 100 mg imidacloprid and 10 mg § 524.1132 Hydrocortisone, miconazole, moxidectin for use as in paragraphs and gentamicin otic suspension. (d)(2) and (d)(3) of this section. (a) Specifications. Each milliliter (b) Sponsor. See No. 000859 in (mL) of suspension contains 1.11 milli- § 510.600(c) of this chapter. grams (mg) of hydrocortisone (c) Special considerations. Federal law aceponate, 15.1 mg of miconazole ni- restricts this drug to use by or on the order of a licensed veterinarian. trate, and 1,505 micrograms of (d) Conditions of use—(1) Dogs—(i) gentamicin sulfate. Amount. Topically apply 4.5 mg/lb body (b) Sponsor. See No.051311 in weight (10 mg/kg) imidacloprid and 1.1 § 510.600(c) of this chapter. mg/lb (2.5 mg/kg) moxidectin, once a (c) Conditions of use in dogs—(1) month. Amount. Instill 1.0 mL in the affected (ii) Indications for use—(A) For the ear once daily for 5 days. prevention of heartworm disease (2) Indications for use. For the treat- caused by Dirofilaria immitis; and the ment of otitis externa in dogs associ- treatment and control of intestinal ated with susceptible strains of yeast roundworms (Toxocara canis and (Malassezia pachydermatis) and bacteria Toxascaris leonina), hookworms (Staphylococcus pseudintermedius). (Ancylostoma caninum and Uncinaria (3) Limitations. Federal law restricts stenocephala), and whipworms (Trichuris this drug to use by or on the order of a vulpis); kills adult fleas and treats flea infestations ( ). licensed veterinarian. Ctenocephalides felis (B) For treatment of Dirofilaria [76 FR 78150, Dec. 16, 2011] immitis circulating microfilariae in

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heartworm-positive dogs and the treat- Oesophagostomum radiatum; (adults) ment and control of sarcoptic mange Strongyloides papillosus, Trichuris spp.; caused by Sarcoptes scabiei var. canis. lungworms (adults and fourth-stage (2) Cats—(i) Amount. Topically apply larvae) Dictyocaulus viviparus; cattle 4.5 mg/lb body weight (10 mg/kg) grubs (parasitic stages) Hypoderma imidacloprid and 0.45 mg/lb (1.0 mg/kg) bovis, H. lineatum; mites Sarcoptes moxidectin, once a month. scabiei var. bovis; lice Linognathus vituli, (ii) Indications for use. For the pre- Haematopinus eurysternus, Damalinia vention of heartworm disease caused bovis, Solenoptes capillatus; and horn by Dirofilaria immitis; for the treatment flies Haematobia irritans. and control of ear mite (Otodectes (ii) It controls infections and pre- cynotis) infestations, intestinal vents reinfection with O. ostertagi, O. roundworms (Toxocara cati), and radiatum, H. placei, T. axei, C. punctata, hookworms (Ancylostoma tubaeforme); and C. oncophora for 14 days after kills adult fleas and treats flea infesta- treatment. tions (Ctenocephalides felis). (iii) It controls infections and pre- (3) Ferrets—(i) Amount. Topically vents reinfection with O. radiatum and apply 9.0 mg/lb body weight (20 mg/kg) D. viviparus for 28 days after treatment, imidacloprid and 0.9 mg/lb (2 mg/kg) C. punctata and T. axei for 21 days after moxidectin, once a month. treatment, O. ostertagi, H. placei, C. (ii) Indications for use. For the pre- oncophora, and C. surnabada for 14 days vention of heartworm disease caused after treatment, and D. bovis for 56 by Dirofilaria immitis; kills adult fleas days after treatment. (Ctenocephalides felis) and is indicated (3) Limitations. Do not treat cattle for the treatment of flea infestations within 48 days of slaughter. Because a on ferrets. withdrawal time in milk has not been [72 FR 10597, Mar. 9, 2007, as amended at 78 established, do not use in female dairy FR 73698, Dec. 9, 2013] cattle of breeding age. A withdrawal period has not been established for this § 524.1193 Ivermectin topical solution. product on preruminating calves. Do (a) Specifications. Each milliliter not use on calves to be processed for (mL) of solution contains 5 milligrams veal. of ivermectin. (b) Sponsors. See sponsors in [55 FR 50551, Dec. 7, 1990, as amended at 62 FR 38908, July 21, 1997; 62 FR 63271, Nov. 28, § 510.600(c) of this chapter for use as in 1997; 63 FR 44385, Aug. 19, 1998; 66 FR 13236, paragraph (e) of this section. Mar. 5, 2001; 66 FR 63165, Dec. 5, 2001; 68 FR (1) Nos. 050604, 055529, 058829, 061623 3817, Jan. 27, 2003; 68 FR 4713, Jan. 30, 2003; 69 for use as in paragraphs (e)(1), (e)(2)(i), FR 501, Jan. 6, 2004; 69 FR 62181, Oct. 25, 2004; (e)(2)(iii), and (e)(3) of this section. 71 FR 13542, Mar. 16, 2006; 72 FR 6464, Feb. 12, (2) Nos. 000859, 054925, and 086001 for 2007; 74 FR 36112, July 22, 2009; 75 FR 26648, use as in paragraphs (e)(1), (e)(2)(i), May 12, 2010; 76 FR 81807, Dec. 29, 2011; 78 FR (e)(2)(ii), and (e)(3) of this section. 17597, Mar. 22, 2013; 78 FR 63872, Oct. 25, 2013] (c) Related tolerances. See § 556.344 of § 524.1195 Ivermectin otic suspension. this chapter. (d) Special considerations. See § 500.25 (a) Specifications. Each tube contains of this chapter. 0.5 milliliter (mL) of a 0.01 percent sus- (e) Conditions of use in cattle—(1) pension of ivermectin. Amount. One mL per 22 pounds (0.5 mil- (b) Sponsor. See No. 000010 in ligram per kilogram) of body weight § 510.600(c) of this chapter. applied topically to the back of the (c) Conditions of use—(1) Amount. Ad- animal. minister the contents of one 0.5-mL (2) Indications for use—(i) It is used tube topically into each external ear for the treatment and control of: Gas- canal. trointestinal roundworms (adults and (2) Indications for use. For the treat- fourth-stage larvae) Ostertagia ostertagi ment of adult ear mite (Otodectes (including inhibited stage), Haemonchus cynotis) infestations in cats and kittens placei, Trichostrongylus axei, T. 4 weeks of age and older. Effectiveness colubriformis, Cooperia oncophora, C. against eggs and immature stages has punctata, C. surnabada, not been proven.

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(3) Limitations. Federal law restricts to bacteria sensitive to kanamycin. this drug to use by or on the order of a For prophylaxis in traumatic condi- licensed veterinarian. tions, removal of foreign bodies, and [66 FR 7578, Jan. 24, 2001, as amended at 74 intraocular surgery. FR 26782, June 4, 2009] (3) Limitations. Federal law restricts this drug to use by or on the order of a § 524.1200 Kanamycin ophthalmic and licensed veterinarian. topical dosage forms. [79 FR 10970, Feb. 27, 2014] § 524.1200a Kanamycin ophthalmic ointment. § 524.1204 Kanamycin, amphomycin, and hydrocortisone ointment. (a) Specifications. Each gram of oint- ment contains 3.5 milligrams (a) Specifications. Each gram of oint- kanamycin activity as kanamycin sul- ment contains 5 milligrams kanamycin fate. activity as kanamycin sulfate, 5 milli- (b) Sponsor. See No. 054771 in grams of amphomycin activity as the § 510.600(c) of this chapter. calcium salt, and 10 milligrams of hy- (c) Conditions of use in dogs—(1) drocortisone acetate. Amount. Apply a thin film to the af- (b) Sponsor. See No. 054771 in fected eye three or four times daily or § 510.600(c) of this chapter. more frequently if deemed advisable. (c) Conditions of use in dogs—(1) Treatment should be continued for at Amount. Apply to the affected areas of least 48 hours after the eye appears the skin at least twice daily. In severe normal. or widespread lesions it may be desir- (2) Indications for use. For the treat- able to apply the ointment more than ment of various eye infections (con- twice daily. After some improvement is junctivitis, blepharitis, dacryocystitis, observed, treatment can usually be re- keratitis, and corneal ulcerations) due duced to once daily. to bacteria sensitive to kanamycin. (2) Indications for use. For the treat- For prophylaxis in traumatic condi- ment of acute otitis externa, furuncu- tions, removal of foreign bodies, and losis, folliculitis, pruritus, anal gland intraocular surgery. infections, erythema, decubital ulcers, (3) Limitations. Federal law restricts superficial wounds, and superficial ab- this drug to use by or on the order of a scesses associated with bacterial infec- licensed veterinarian. tions caused by organisms susceptible to one or both . [79 FR 10969, Feb. 27, 2014] (3) Limitations. Federal law restricts this drug to use by or on the order of a § 524.1200b Kanamycin ophthalmic so- lution. licensed veterinarian. (a) Specifications. Each milliliter of [79 FR 10970, Feb. 27, 2014] solution contains 10 milligrams kanamycin activity as kanamycin sul- § 524.1240 Levamisole. fate. (a) Specifications. The drug contains (b) Sponsor. See No. 054771 in 200 milligrams of levamisole per milli- § 510.600(c) of this chapter. liter of diethylene glycol monobutyl (c) Conditions of use in dogs—(1) ether (DGME) solution. Amount. Instill a few drops into the af- (b) Sponsors. See Nos. 000061 and fected eye every 3 hours or more fre- 054771 in § 510.600(c) of this chapter. quently if deemed advisable. Admin- (c) Related tolerances. See § 556.350 of ister as frequently as possible for the this chapter. first 48 hours, after which the fre- (d) Conditions of use. Cattle—(1) quency of applications may be de- Amount. 2.5 milliliters per 110 pounds creased. Treatment should be contin- (10 milligrams of levamisole per kilo- ued for at least 48 hours after the eye gram) of body weight as a single dose appears normal. topically to the back of the animal. (2) Indications for use. For the treat- (2) Indications for use. Anthelmintic ment of various eye infections (con- effective against stomach worms junctivitis, blepharitis, dacryocystitis, (Haemonchus, Trichostrongylus, keratitis, and corneal ulcerations) due Ostertagia), intestinal worms

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(Trichostrongylus, Cooperia, (c) Conditions of use in dogs and cats— Nematodirus, Bunostomum, (1) Amount. Apply once daily by rub- Oesophagostomum, Chabertia), and bing into or spraying a light covering lungworms (Dictyocaulus). on the infected site and the immediate (3) Limitations. Conditions of constant surrounding vicinity. Continue treat- helminth exposure may require re- ment for 2 to 4 weeks until infection is treatment within 2 to 4 weeks after the completely eradicated as determined first treatment. Cattle must not be by appropriate laboratory examina- slaughtered within 9 days following tion. last treatment. Do not administer to (2) Indications for use. For topical dairy animals of breeding age. Do not treatment of infections caused by treat animals before dipping or prior to Microsporum canis, Microsporum exposure to heavy rain. Consult your gypseum, and Trichophyton veterinarian for assistance in the diag- mentagrophytes. nosis, treatment, and control of para- (3) Limitations. Federal law restricts sitism, and before using in severely de- this drug to use by or on the order of a bilitated animals. licensed veterinarian. [52 FR 10887, Apr. 6, 1987, as amended at 53 [71 FR 13542, Mar. 16, 2006] FR 7504, Mar. 9, 1988; 62 FR 61626, Nov. 19, 1997; 67 FR 78355, Dec. 24, 2002; 79 FR 10970, § 524.1445 Miconazole, polymixin B, Feb. 27, 2014] and prednisolone suspension. (a) Specifications. Each milliliter of § 524.1376 2-Mercaptobenzothiazole so- suspension contains 23 milligrams (mg) lution. miconazole nitrate, 0.5293 mg (a) Specifications. The drug contains polymixin B sulfate, and 5 mg prednis- 1.3 percent 2-mercaptobenzothiazole in olone acetate. a suitable solvent. (b) Sponsor. See No. 000986 in (b) Sponsor. See 017135 in § 510.600(c) of § 510.600(c) of this chapter. this chapter. (c) Conditions of use in dogs—(1) (c) Conditions of use—(1) Amount. Amount. Instill five drops in the ear Apply twice daily to affected area. canal twice daily for 7 consecutive (2) Indications for use. For dogs as an days. aid in the treatment of hot spots (2) Indications for use. For the treat- (moist dermatitis) and as first aid for ment of canine otitis externa associ- scrapes and abrasions. ated with susceptible strains of yeast (3) Limitations. Clip hair from affected (Malassezia pachydermatis) and bacteria area before applying. If no improve- (Staphylococcus pseudintermedius). ment is seen within 1 week, consult a (3) Limitations. Federal law restricts veterinarian. this drug to use by or on the order of a [48 FR 15618, Apr. 12, 1983, as amended at 65 licensed veterinarian. FR 50913, Aug. 22, 2000; 68 FR 33381, June 4, [ 75 FR 4693, Jan. 29, 2010, as amended at 77 2003] FR 46613, Aug. 6, 2012]

§ 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 milbemycin oxime. 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.

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(3) Limitations. Federal law restricts use on calves to be processed for veal. this drug to use by or on the order of a See § 500.25 of this chapter. licensed veterinarian. (2) Dogs—(i) Amount. Administer topi- [65 FR 13905, Mar. 15, 2000, as amended at 66 cally a minimum of 1.1 mg per pound FR 13849, Mar. 8, 2001] (lb) (2.5 mg/kg) of body weight, once monthly using the appropriate pre- § 524.1450 Moxidectin. loaded applicator tube. (a) Specifications. Each milliliter of (ii) Indications for use. For the pre- solution contains: vention of heartworm disease caused (1) 5 milligrams (mg) moxidectin (0.5 by Dirofilaria immitis, as well as the percent solution). treatment and control of intestinal (2) 25 mg moxidectin (2.5 percent so- hookworm (Ancylostoma caninum lution). (adult, immature adult, and L4 larvae) (b) Sponsors. See sponsor numbers in and Uncinaria stenocephala (adult, im- § 510.600 of this chapter: mature adult, and L4 larvae)), (1) No. 000010 for use of product de- roundworm (Toxocara canis (adult and scribed in paragraph (a)(1) of this sec- L4 larvae) and Toxascaris leonina tion as in paragraph (d)(1) of this sec- (adult)), and whipworm (Trichuris vulpis tion; (adult)) infections in dogs and puppies (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; 80 FR 53460, Sept. 4, 2015] (ii) Indications for use. Beef and dairy cattle: For treatment and control of in- § 524.1465 Mupirocin. ternal and external parasites: gastro- (a) Specifications. Each gram of oint- intestinal roundworms (Ostertagia ment contains 20 milligrams ostertagi (adult and L4, including inhib- mupirocin. ited larvae), Haemonchus placei (adult (b) Sponsors. See Nos. 025463, 026637, and L4), Trichostrongylus axei (adult 051672, and 054771 in § 510.600(c) of this and L4), T. colubriformis (adult and L4), 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 eurysternus, Solenopotes capillatus, [72 FR 18119, Apr. 11, 2007, as amended at 75 Bovicola (Damalinia) bovis); and horn FR 79296, Dec. 20, 2010; 78 FR 52854, Aug. 27, 2013; 79 FR 10970, Feb. 27, 2014] flies (Haematobia irritans). To control infections and to protect from reinfec- § 524.1484 Neomycin ophthalmic and tion with H. placei for 14 days after 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,

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equivalent to 3.5 milligrams of neomy- day and these daily applications con- cin base, 1 milligram of isoflupredone tinued in accordance with the clinical acetate, 5 milligrams of tetracaine hy- response. drochloride and .2 milligram of (2) Indications for use. For the treat- myristyl-gamma-picolinium chloride ment of acute otitis externa in dogs in each gram of the product in a special and to a lesser degree, chronic otitis adherent powder base. externa in dogs. It also is effective in (b) Sponsor. See No. 054771 in treating anal gland infections and § 510.600(c) of this chapter. moist dermatitis in the dog and is a (c) Conditions of use in horses, dogs, useful for minor cuts, lacera- and cats—(1) Amount. Apply to affected tions, abrasions, and post-surgical areas as a dusting powder. therapy in the horse, cat, and dog. It (2) Indications for use. For the treat- may also be used following amputation ment or as adjunctive therapy of cer- of dewclaws, tails and claws, following tain ear and skin conditions caused by ear trimming and castrating oper- or associated with neomycin-suscep- ations. tible organisms and/or allergy; as a su- (3) Limitations. Federal law restricts perficial dressing applied to minor this drug to use by or on the order of a cuts, wounds, lacerations, abrasions, licensed veterinarian. and for postsurgical application where reduction of pain and inflammatory re- [40 FR 13873, Mar. 27, 1975, as amended at 43 sponse is deemed desirable; as a dust- FR 18172, Apr. 28, 1978; 79 FR 10970, Feb. 27, 2014] ing powder following amputation of tails, claws, and dewclaws and fol- § 524.1484d Neomycin, hydrocortisone, lowing ear trimming, castrating, and and tetracaine otic ointment. such surgical procedures as (a) The product con- ovariohysterectomies. For the treat- Specifications. tains 5 milligrams of neomycin sulfate, ment of acute otitis externa, acute equivalent to 3.5 milligrams of neomy- moist dermatitis, and interdigital der- cin base, 5 milligrams of hydro- matitis in dogs. (3) Limitations. Federal law restricts cortisone acetate, and 5 milligrams of this drug to use by or on the order of a tetracaine hydrochloride in each gram licensed veterinarian. of ointment. (b) Sponsor. See No. 054771 in [40 FR 13873, Mar. 27, 1975, as amended at 43 § 510.600(c) of this chapter. FR 18172, Apr. 28, 1978; 79 FR 10970, Feb. 27, (c) Conditions of use in dogs and cats— 2014] (1) Amount. Instill a quantity of oint- § 524.1484c Neomycin, isoflupredone, ment sufficient to fill the external ear and tetracaine ointment. canal; may be applied one to three times daily. (a) Specifications. The drug contains 5 (2) For the treat- milligrams of neomycin sulfate (equiv- Indications for use. ment of ear canker and other inflam- alent to 3.5 milligrams of neomycin matory conditions of the external ear base), 1 milligram of isoflupredone ace- canal, acute otitis externa and, to a tate, and 5 milligrams of tetracaine hy- lesser degree, chronic otitis externa. drochloride in each gram of ointment. (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.

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(b) Sponsor. See No. 054771 in twice daily. In treating otitis externa, § 510.600(c) of this chapter. instill 5 to 15 drops in the ear twice (c) Conditions of use in dogs—(1) daily. Treat for up to 7 days. Amount. Instill 1 to 2 drops per eye (2) Indications for use. As an aid in the every 6 hours. treatment of bacterial, mycotic, and (2) Indications for use. For the treat- inflammatory dermatoses and otitis ment of bacterial infections associated externa. with topical ophthalmological condi- (3) Limitations. Federal law restricts tions such as corneal injuries, super- this drug to use by or on the order of a ficial keratitis, conjunctivitis, licensed veterinarian. keratoconjunctivitis, and blepharitis. (3) Limitations. Federal law restricts [40 FR 13873, Mar. 27, 1975, as amended at 62 this drug to use by or on the order of a FR 63271, Nov. 28, 1997; 79 FR 10971, Feb. 27, licensed veterinarian. 2014; 80 FR 61297, Oct. 13, 2015] [40 FR 13873, Mar. 27, 1975, as amended at 61 § 524.1484h Neomycin, penicillin, poly- FR 5507, Feb. 13, 1996; 79 FR 10970, Feb. 27, myxin B, and hydrocortisone sus- 2014] pension. § 524.1484f Neomycin, prednisolone, (a) Specifications. Each milliliter of and tetracaine otic suspension. suspension contains 25 milligrams of neomycin sulfate equivalent to 17.5 (a) Specifications. The product con- tains 5 milligrams of neomycin sulfate milligrams of neomycin, 10,000 inter- equivalent to 3.5 milligrams of neomy- national units of penicillin G procaine, cin base, 2.5 milligrams of prednisolone 5,000 international units of polymyxin acetate, and 5 milligrams of tetracaine B sulfate, 2 milligrams of hydro- hydrochloride in each milliliter of ster- cortisone acetate, and 1.25 milligrams ile suspension. of hydrocortisone sodium succinate. (b) Sponsor. See No. 054771 in (b) Sponsor. See No. 054771 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 in dogs—(1) (1) Amount. Instill 2 to 6 drops in the Amount. Rub a small amount into the external ear canal 2 or 3 times daily. affected area 1 to 3 times a day. After (2) Indications for use. For the treat- definite improvement, apply once daily ment of acute otitis externa and, to a or every other day. lesser degree, chronic otitis externa; as (2) Indications for use. For the treat- treatment or adjunctive therapy of cer- ment of summer eczema, atopic derma- tain ear conditions caused by or associ- titis, interdigital eczema, and otitis ated with neomycin-susceptible orga- externa caused by bacteria susceptible nisms and/or allergy. to neomycin, penicillin, and polymyxin (3) Limitations. Federal law restricts B. this drug to use by or on the order of a (3) Limitations. Federal law restricts licensed veterinarian. this drug to use by or on the order of a [40 FR 13873, Mar. 27, 1975, as amended at 79 licensed veterinarian. FR 10971, Feb. 27, 2014] (d) Conditions of use—dogs—(1) Amount. Rub a small amount into the § 524.1484g Neomycin, thiabendazole, involved area 1 to 3 times a day. After and dexamethasone solution. 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 methasone. caused by bacteria susceptible to neo- (b) Sponsors. See Nos. 026637 and mycin, penicillin, and polymyxin B. 050604 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

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by or on the order of a licensed veteri- anterior segment of the eye, such as narian. those associated with allergic reactions or gross irritants. [59 FR 5105, Feb. 3, 1994, as amended at 79 FR 10971, Feb. 27, 2014] (3) Limitations. Federal law restricts this drug to use by or on the order of a § 524.1484i Neomycin and hydro- licensed veterinarian. cortisone ointment. [79 FR 10971, Feb. 27, 2014] (a) Specifications. The drug contains 5 milligrams of neomycin sulfate, equiv- § 524.1484k Prednisolone and neomy- alent to 3.5 milligrams of neomycin cin suspension. base, and 5 milligrams of hydro- (a) Specifications. Each milliliter of cortisone acetate in each gram of oint- suspension contains 2.5 milligrams of ment.1 prednisolone acetate and 5 milligrams (b) Sponsor. See No. 054771 in of neomycin sulfate equivalent to 3.5 § 510.600(c) of this chapter. milligrams of neomycin base. (c) Conditions of use in dogs and cats— (b) Sponsor. See No. 054771 in (1) Amount. Apply 3 or 4 times daily § 510.600(c) of this chapter. into the conjunctival sac. With im- (c) Conditions of use in dogs and cats— provement, frequency may be reduced (1) Amount. For beginning treatment of to 2 or 3 times daily. For treatment of acute ocular place 1 or 2 ear canker and other inflammatory drops in the conjunctival sac 3 to 6 conditions of the external ear canal, times during a 24 hour period. When fill external ear canal 1 to 3 times improvement occurs, reduce the dosage daily. to 1 drop 2 to 4 times daily. For otitis (2) Indications for use. For the treat- externa, place 2 to 6 drops in the exter- ment of infections, allergic and trau- nal ear canal 2 or 3 times daily. matic keratitis, conjunctivitis, acute (2) Indications for use. For the treat- otitis externa and, to a lesser degree, ment of treating infectious, allergic chronic otitis externa. and traumatic keratitis and conjunc- (3) Limitations. Federal law restricts tivitis, acute otitis externa, and chron- this drug to use by or on the order of a ic otitis externa. licensed veterinarian. (3) Limitations. Federal law restricts [43 FR 40456, Sept. 12, 1978, as amended at 79 this drug to use by or on the order of a FR 10971, Feb. 27, 2014] licensed veterinarian. [79 FR 10971, Feb. 27, 2014] § 524.1484j Neomycin and prednisolone ophthalmic ointment. § 524.1580 Nitrofurazone topical dos- (a) Specifications. Each gram of oint- age forms. ment contains prednisolone sodium phosphate equivalent to 2.5 milligrams § 524.1580a Nitrofurazone ointment. prednisolone 21-phosphate and 5 milli- (a) Specifications. The drug contains grams neomycin sulfate equivalent to 0.2 percent nitrofurazone in a water- 3.5 milligrams neomycin base. soluble base. (b) Sponsor. See No. 050604 in (b) Sponsors. See sponsors in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— (1) See Nos. 054628, 054925, 058005, (1) Amount. A small quantity of the 059051, and 061623 for use on dogs, cats, ointment should be expressed into the or horses. conjunctival sac 4 times a day (at in- (2) See No. 017135 for use on dogs and tervals of 1 to 8 hours) for a few days horses. until there is a favorable response, (3) See Nos. 017153 and 058829 for use then the frequency of application may on horses. be reduced to twice daily as long as the (c) [Reserved] condition remains under control. (d) Conditions of use—(1) Amount. Treatment may require from a few Apply directly on the lesion with a days to several weeks. spatula or first place on a piece of (2) Indications for use. For use in su- gauze. The preparation should remain perficial ocular inflammations or infec- on the lesion for at least 24 hours. Use tions limited to the conjunctiva or the of a bandage is optional.

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(2) Indications for use. For prevention cent butacaine sulfate in a water-solu- or treatment of surface bacterial infec- ble base. tions of wounds, burns, and cutaneous (b) Sponsor. See No. 054925 in ulcers of dogs, cats, or horses. § 510.600(c) of this chapter. (3) Limitations. For use only on dogs, (c) Conditions of use—(1) Indications cats, and horses. Do not use in horses for use. For prevention or treatment of intended for human consumption. Fed- surface bacterial infections of ears, eral law prohibits the use of this prod- wounds, burns, and cutaneous ulcers of uct in food-producing animals. In case dogs, cats, and horses. of deep or puncture wounds or serious (2) Limitations. Apply directly on the burns, use only as recommended by lesion with a spatula or first place on a veterinarian. If redness, irritation, or piece of gauze. Use of a bandage is op- swelling persists or increases, dis- tional. The preparation should remain continue use; consult veterinarian. on the lesion for at least 24 hours. The [46 FR 43402, June 27, 1980. Redesignated at 79 dressing may be changed several times FR 10971, Feb. 27, 2014] daily or left on the lesion for a longer period. For use only on dogs, cats, and EDITORIAL NOTE: For FEDERAL REGISTER ci- horses (not for food use). In case of tations affecting § 524.1580a, see the List of deep or puncture wounds or serious CFR Sections Affected, which appears in the Finding Aids section of the printed volume burns, use only as recommended by a and at www.fdsys.gov. veterinarian. If redness, irritation, or swelling persists or increases, dis- § 524.1580b Nitrofurazone soluble pow- continue use; consult veterinarian. der. [49 FR 9417, Mar. 13, 1984, as amended at 71 (a) Specifications. The drug contains FR 13542, Mar. 16, 2006. Redesignated at 79 FR 0.2 percent nitrofurazone in a water- 10971, Feb. 27, 2014; 79 FR 10971, Feb. 27, 2014] soluble base. (b) Sponsor. See Nos. 054628 and 059051 § 524.1600 Nystatin ophthalmic and in § 510.600(c) of this chapter. topical dosage forms. (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. (2) Indications for use. For prevention (a) Specifications. Each milliliter of or treatment of surface bacterial infec- petrolatum base or each gram of van- tions of wounds, burns, skin ulcers, and ishing cream base ointment contains: abscesses after incision. 100,000 units of nystatin; neomycin sul- 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 only as recommended by veterinarian. thiostrepton; and 1.0 milligram of If redness, irritation, or swelling per- triamcinolone acetonide. 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, (c) Conditions of use—(1) Amount. (i) 1983; 53 FR 40728, Oct. 18, 1988; 54 FR 30542, For topical dermatological use: Clean July 21, 1989; 56 FR 50653, Oct. 8, 1991; 59 FR 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] (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 may be advisable.

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

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(c) Conditions of use in dogs and cats— dogs, cats, cattle, sheep, and horses); (1) Amount. A small quantity should be ocular infections due to secondary bac- sprayed on the affected surface by terial complications associated with holding the container about 6 inches distemper in dogs; and ocular infec- from the area to be treated and press- tions due to bacterial inflammatory ing the nozzle for 1 or 2 seconds. Only conditions which may occur secondary sufficient spray to coat the skin thinly to other infectious diseases in dogs, is necessary. The application of small cats, cattle, sheep, and horses. amounts at frequent intervals will give (3) Limitations. Allergic reactions best results. Before treating animals may occasionally occur. Treatment with long or matted hair, it may be should be discontinued if reactions are necessary to clip the affected area or severe. If new infections due to nonsen- 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 N-(Mercaptomethyl) phthal- (2) Indications for use. For the relief of imide S-(O,O-dimethyl discomfort and continued treatment of phosphorodithioate) emulsifiable many allergic, infectious, and trau- liquid. matic skin conditions; for the preven- (a) Specifications. The emulsifiable tion of bacterial infections in super- liquid contains 11.6 percent N- ficial wounds, cuts, and abrasions, (mercaptomethyl) phthalimide S-(O,O- treatment of allergic dermatoses, in- dimethyl phosphorodithioate). cluding urticaria, eczemas, insect (b) Sponsor. See No. 000061 in bites, and cutaneous drug reactions, in- § 510.600(c) of this chapter. fections associated with minor burns (c) Conditions of use—(1) Methods of and wounds, and nonspecific pruritus. application. Methods of application to (3) Limitations. Keep away from eyes control the following conditions on or other mucous membranes; avoid in- beef cattle: haling; use with adequate ventilation; Dilution rate in case of deep or puncture wounds or To control/method of use (gal. drug: gal. serious burns, consult a veterinarian. of water)

[40 FR 13873, Mar. 27, 1975, as amended at 79 Grubs: FR 10972, Feb. 27, 2014] Dip ...... 1:60 Pour-on ...... 1:2 Spray ...... 1:49 § 524.1662b Oxytetracycline and poly- Lice: myxin B ophthalmic ointment. Dip ...... 1:60 (a) Specifications. Each gram of the Pour-on ...... 1:2 or 1:5 Spray ...... 1:49 or 1:100 ointment contains oxytetracycline hy- Hornflies: drochloride equivalent to 5 milligrams Dip ...... 1:60 of oxytetracycline and 10,000 units of Spray ...... 1:49 or 1:100 Cattle Ticks: polymyxin B sulfate. Dip ...... 1:60 or 1:240 (b) Sponsor. See No. 054771 in Spray ...... 1:49 § 510.600(c) of this chapter. Southern cattle ticks: Dip ...... 1:60 or 1:240 (c) Conditions of use in dogs and cats— Spray ...... 1:49 (1) Amount. Administer topically to the Scabies mites:. eye two to four times daily. Dip ...... 1:60 Lone Star Ticks: (2) Indications for use. For the prophy- Dip ...... 1:60 laxis and local treatment of superficial Spray ...... 1:49 or 1:100 ocular infections due to oxytetracycline- and polymyxin-sen- (i) Dip vat procedure. (a) Prior to sitive organisms including ocular in- charging vat, empty old contents and fections due to streptococci, thoroughly clean the vat. Dip vats rickettsiae, E. coli, and A. aerogenes should be calibrated to maintain an ac- (such as conjunctivitis, keratitis, pink- curate dilution. Add water, then drug eye, corneal ulcer, and blepharitis in to the vat according to the dilution

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rate indicated in the table. Add super (iii) Pour-on method. Dilute the drug phosphate at a rate of 100 pounds per with water according to table by slow- 1,000 gallons of vat solution. Super ly adding water to the product while phosphate is added to control the pH of stirring. Apply 1 ounce of the diluted the solution and ensure vat stability. mixture per 100 pounds of body weight Super phosphate is usually available at (to a maximum of 8 ounces per head) most fertilizer dealers as 0–45–0 or 0–46– down the center line of the back. 0. Stir the dip thoroughly, preferably (2) Timing of applications for cattle with a compressed air device; however, grub control. For optimum cattle grub any form of thorough mixing is ade- control, it is important to treat as quate. Re-stir vat contents prior to soon as possible after the heel fly sea- each use. During the dipping operation, son, before the grub larvae reach the each time the dip’s volume is reduced gullet or spinal canal, as the rapid kill by 1⁄8 to 1⁄4 of its initial volume, replen- of large numbers of larvae in these tis- ish with water and add the drug at a sues may cause toxic side effects, such rate of 1 gallon for each 50 or 200 gal- as bloat, salivation, staggering, and pa- lons water added—depending on dilu- ralysis. tion rate 1:60 or 1:240. Also add super (3) Treatment regimens. (i) Control of phosphate as necessary to maintain pH scabies mites requires two treatments, between 4.5 and 6.5. Stir well and re- 10 to 14 days apart. sume dipping. Repeat replenishment (ii) Control of Lone Star Ticks and process as necessary. For evaportion, hornflies requires two treatments, 7 add additional water accordingly. For days apart. added water due to rainfall, merely re- (4) Warnings. The drug is a cholin- plenish dip with the product according esterase inhibitor. Do not use this drug to directions. If overflow occurs, either on animals simultaneously or within a analyze for drug concentration and ad- few days before or after treatment with just accordingly or dispose of vat con- or exposure to cholinesterase-inhib- tents and recharge. Check pH after iting drugs, pesticides, or chemicals. 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 ( ) ( ) With use of b Dip maintenance. 1 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.

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(d) Related tolerances. See 40 CFR (3) Limitations. Keep away from eyes 180.261. or other mucous membranes; avoid in- haling; use with adequate ventilation; [40 FR 13873, Mar. 27, 1975, as amended at 46 in case of deep or puncture wounds or FR 27914, May 22, 1981; 48 FR 39607, Sept. 1, 1983; 54 FR 51021, Dec. 12, 1989; 61 FR 8873, serious burns, consult a veterinarian. Mar. 6, 1996; 62 FR 61626, Nov. 19, 1997; 63 FR (d) Conditions of use. (1) The drug is 5255, Feb. 2, 1998] indicated for use as a topical oph- thalmic anesthetic in animals. It is § 524.1982 Proparacaine ophthalmic used as an anesthetic in cauterization solution. of corneal ulcers, removal of foreign (a) Specifications. The drug is an aque- bodies and sutures from the cornea, ous solution containing 0.5 percent and measurement of intraocular pres- proparacaine hydrochloride, 2.45 per- sure (tonometry) when glaucoma is cent glycerin as a stabilizer, and 0.2 suspected. Local applications may also percent chlorobutanol (choral deriva- be used as an aid in the removal of for- tive) and 1:10,000 benzalkonium chlo- eign bodies from the nose and ear ride as preservatives. canal, as an accessory in the examina- (b) Sponsor. See No. 054771 in tion and treatment of painful otitis, in § 510.600(c) of this chapter. minor surgery, and prior to catheter- 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 [40 FR 13873, Mar. 27, 1975, as amended at 50 topical ophthalmic anesthetic. It is FR 41490, Oct. 11, 1985; 79 FR 10972, Feb. 27, used as an anesthetic in cauterization 2014] of corneal ulcers, removal of foreign bodies and sutures from the cornea, § 524.2098 Selamectin. and measurement of intraocular pres- (a) Specifications. Each milliliter con- sure (tonometry) when glaucoma is tains 60 or 120 milligrams of suspected; as an aid in the removal of selamectin. foreign bodies from the nose and ear (b) Sponsor. See 054771 in § 510.600(c) of canal; as an accessory in the examina- this chapter. tion and treatment of painful otitis, in (c) [Reserved] minor surgery, and prior to catheter- (d) Conditions of use—(1) Amount. 2.7 ization. milligrams of selamectin, topically,

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per pound (6 milligrams per kilogram) § 524.2350 Tolnaftate cream. of body weight. (a) Specifications. The drug contains 1 (2) Indications for use. Kills adult fleas percent tolnaftate in an anhydrous and prevents flea eggs from hatching cream base. for 1 month, and it is indicated for the (b) Sponsor. See No. 000061 in prevention and control of flea infesta- § 510.600(c) of this chapter. tions (Ctenocephalides felis), prevention (c) Conditions of use—(1) Amount. of heartworm disease caused by Apply a small amount of the cream to Dirofilaria immitis, and treatment and the affected areas once or twice a day control of ear mite (Otodectes cynotis) for 2 to 4 weeks. infestations in dogs and cats. Treat- (2) Indications for use. For the treat- ment and control of sarcoptic mange ment of ringworm lesions due to (Sarcoptes scabiei) and control of tick Microsporum canis and Microsporum (Dermacentor variabilis) infestations in gypseum. dogs. Treatment and control of intes- tinal hookworm (Ancylostoma (3) Limitations. Federal law restricts tubaeforme) and roundworm (Toxocara this drug to use by or on the order of a cati) infections in cats. For dogs 6 licensed veterinarian. weeks of age and older, and cats 8 [79 FR 10972, Feb. 27, 2014] weeks of age and older. (3) Limitations. Federal law restricts § 524.2482 Triamcinolone spray. this drug to use by or on the order of a (a) Specifications. Each milliliter of licensed veterinarian. solution contains 0.15 milligrams [64 FR 37401, July 12, 1999, as amended at 64 triamcinolone acetonide. FR 48707, Sept. 8, 1999; 65 FR 45282, July 21, (b) Sponsor. See No. 051311 in 2000; 74 FR 19878, Apr. 30, 2009; 79 FR 10972, § 510.600(c) of this chapter. Feb. 27, 2014] (c) Conditions of use in dogs—(1) Amount. Apply sufficient pump sprays § 524.2101 Selenium disulfide suspen- to uniformly and thoroughly wet the sion. affected areas while avoiding run off of (a) Specifications. The product con- excess product. Administer twice daily tains 0.9-percent weight in weight (w/w) for 7 days, then once daily for 7 days, selenium disulfide (1-percent weight in then every other day for an additional volume (w/v)). 14 days (28 days total). (b) Sponsors. See Nos. 000061, 017135, (2) Indications for use. For the control and 050604 in § 510.600(c) of this chapter. of pruritus associated with allergic der- (c) Conditions of use on dogs—(1) Indi- matitis. 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. [68 FR 4916, Jan. 31, 2003, as amended at 78 (2) Amount. One to 2 ounces per appli- FR 17868, Mar. 25, 2013] cation. (3) Limitations. Use carefully around § 524.2483 Triamcinolone cream. scrotum and eyes, covering scrotum (a) Specifications. The vanishing with petrolatum. Allow the shampoo to cream contains 0.1 percent remain for 5 to 15 minutes before thor- triamcinolone acetonide. ough rinsing. Repeat treatment once or (b) Sponsor. See Nos. 000010 and 054925 twice a week. If conditions persist or if in § 510.600(c) of this chapter. rash or irritation develops, discontinue (c) —(1) use and consult a veterinarian. Conditions of use in dogs Amount. Rub into affected areas two to [47 FR 53351, Nov. 26, 1982, as amended at 48 four times daily for 4 to 10 days. FR 32762, July 19, 1983; 54 FR 36962, Sept. 6, (2) Indications for use. For topical 1989; 56 FR 9623, Mar. 7, 1991; 58 FR 41025, treatment of allergic dermatitis and Aug. 2, 1993; 63 FR 26981, May 15, 1998; 70 FR summer eczema. 50183, Aug. 26, 2005]

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(3) Limitations. Federal law restricts 526.1696c Penicillin G procaine-dihydro- this drug to use by or on the order of a streptomycin sulfate for intramammary licensed veterinarian. infusion (dry cows). 526.1696d Penicillin G procaine-novobiocin [71 FR 13542, Mar. 16, 2006, as amended at 73 for intramammary infusion. FR 79318, Dec. 29, 2008. Redesignated and 526.1810 Pirlimycin. amended at 75 FR 10168, Mar. 5, 2010; 77 FR 60302, Oct. 3, 2012] AUTHORITY: 21 U.S.C. 360b.

§ 524.2620 Liquid crystalline trypsin, § 526.88 Amoxicillin trihydrate for Peru balsam, castor oil. intramammary infusion. (a) Specifications—(1) Each gram of (a) Specifications. Each single dose sy- liquid or aerosol contains 0.12 milli- ringe contains amoxicillin trihydrate gram of crystalline trypsin, 87.0 milli- equivalent to 62.5 milligrams of grams of Peru balsam, and 788.0 milli- amoxicillin. grams of castor oil. (b) Sponsor. See No. 000061 in (2) Each gram of liquid or aerosol § 510.600(c) of this chapter. contains 0.1 milligram of crystalline (c) Related tolerances. See § 556.38 of trypsin, 72.5 milligrams of Peru bal- this chapter. sam, and 800 milligrams of castor oil. (d) Conditions of use—Lactating cows— (b) Sponsors. See sponsor numbers in (1) Amount. One syringe (equivalent to § 510.600(c) of this chapter for use as in 62.5 milligrams amoxicillin) per quar- paragraph (c) in this section: ter. (1) No. 051079 for use of product de- (2) Indications for use. For the treat- scribed in paragraph (a)(1). ment of subclinical infectious bovine (2) No. 017135 for use of product de- mastitis due to Streptococcus agalactiae scribed in paragraph (a)(2). and Straphylococcus aureus (penicillin (c) Conditions of use—(1) Amount. sensitive). Apply directly to the wound site. (3) Limitations. Administer after (2) Indications for use. As an aid in the milking. Clean and disinfect the teat. treatment of external wounds and as- Use one syringe per infected quarter sists healing by facilitating the re- every 12 hours for a maximum of 3 moval of necrotic tissue, exudate, and doses. Do not use milk taken from organic debris. treated animals for food purposes with- in 60 hours (5 milkings) after last treat- [79 FR 10973, Feb. 27, 2014] ment. Do not slaughter treated ani- mals for food purposes within 12 days PART 526—INTRAMAMMARY DOS- after the last treatment. Federal law AGE FORM NEW ANIMAL restricts this drug to use by or on the DRUGS order of a licensed veterinarian. [57 FR 37334, Aug. 18, 1992, as amended at 60 Sec. FR 55660, Nov. 2, 1995; 68 FR 44878, July 31, 526.88 Amoxicillin trihydrate for 2003] intramammary infusion. 526.313 Ceftiofur. § 526.313 Ceftiofur. 526.363 Cephapirin benzathine. 526.365 Cephapirin sodium. (a) Specifications. Each single-use, 10- 526.464 Cloxacillin intramammary dosage milliliter syringe of ceftiofur hydro- forms. chloride suspension contains 125 milli- 526.464a Cloxacillin benzathine. grams (mg) or 500 mg ceftiofur equiva- 526.464b Cloxacillin benzathine for intramammary infusion, sterile. lents. 526.464c Cloxacillin sodium for (b) Sponsor. See No. 054771 in intramammary infusion, sterile. § 510.600(c) of this chapter. 526.820 Erythromycin. (c) Related tolerances. See § 556.113 of 526.1130 Hetacillin infusion. this chapter. 526.1590 Novobiocin infusion. (d) Conditions of use in cattle—(1) Lac- 526.1696 Penicillin intramammary dosage tating cows—(i) Amount. Infuse 125 mg forms. 526.1696a Penicillin G procaine. per affected quarter. Repeat treatment 526.1696b Penicillin G procaine-dihydro- in 24 hours. Once daily treatment may streptomycin in soybean oil for be repeated for up to 8 consecutive intramammary infusion (dry cows). days.

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