PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS Authority: 21 U.S.C. 360b. Source: 40 FR 13873, Mar. 27, 1975, unless otherwise noted. § 524.86 Amitraz. (a) Specifications. (b) Sponsor. (c) Conditions of use Indications for use. Demodex canis (2) Amount. (3) Limitations. [47 FR 18589, Apr. 30, 1982, as amended at 79 FR 10967, Feb. 27, 2014] § 524.154 Bacitracin, neomycin, and polymyxin B ophthalmic ointment. (a) Specifications. (1) 500 units bacitracin, 3.5 milligrams (mg) neomycin sulfate (equivalent to 3.5 mg neomycin base), and 10,000 units polymyxin B sulfate; or (2) 400 units bacitracin zinc, 5 mg neomycin sulfate (equivalent to 3.5 mg neomycin base), and 10,000 units polymyxin B sulfate. (b) Sponsors. (1) No. 054771 for use of product described in paragraph (a)(1) as in paragraph (c) of this section. (2) Nos. 000061, 043264, and 086189 for use of product described in paragraph (a)(2) as in paragraph (c) of this section. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [57 FR 37333, Aug. 18, 1992, as amended at 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, Feb. 27, 2014; 80 FR 61297, Oct. 13, 2015; 88 FR 84701, Dec. 6, 2023] § 524.155 Bacitracin, neomycin, polymyxin B, and hydrocortisone ophthalmic ointment. (a) Specifications. (b) Sponsors. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [57 FR 37333, Aug. 18, 1992, as amended at 61 FR 8873, Mar. 6, 1996; 62 FR 61626, Nov. 19, 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, Feb. 27, 2014] § 524.230 Buprenorphine. (a) Specifications. (b) Sponsor. (c) Conditions of use in cats Amount. (2) Indications for use. (3) Limitations. [87 FR 58962, Sept. 29, 2022] § 524.390 Chloramphenicol ophthalmic ointment. (a) Specifications. (b) Sponsors. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [77 FR 4897, Feb. 1, 2012, as amended at 77 FR 64717, Oct. 23, 2012; 79 FR 10967, Feb. 27, 2014] § 524.402 Chlorhexidine. (a) Specifications. (b) Sponsors. (c) Conditions of use in dogs, cats, and horses Indications for use. (2) Limitations. [72 FR 265, Jan. 4, 2007, as amended at 79 FR 10967, Feb. 27, 2014] § 524.450 Clotrimazole. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. 1/4 (2) Indications of use. Microsporum canis Trichophyton mentagrophytes. (3) Limitations. [40 FR 48128, July 18, 1980, as amended at 79 FR 10967, Feb. 27, 2014; 86 FR 14820, Mar. 19, 2021] § 524.463 Copper naphthenate. (a) Amount. (b) Sponsors. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [47 FR 4250, Jan. 29, 1982, as amended at 68 FR 55825, Sept. 29, 2003; 71 FR 38074, July 5, 2006; 79 FR 10967, Feb. 27, 2014] § 524.575 Cyclosporine ophthalmic ointment. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. 1/4 (2) Indications for use. (3) Limitations. [60 FR 48651, Sept. 20, 1995, as amended at 62 FR 48940, Sept. 18, 1997; 79 FR 10967, Feb. 27, 2014] § 524.590 Diclofenac. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use in horses. (3) Limitations. [69 FR 40767, July 7, 2004, as amended at 74 FR 26782, June 4, 2009; 74 FR 47436, Sept. 16, 2009] § 524.660 Dimethyl sulfoxide. (a) Specifications. (2) Each milliliter (mL) of gel product contains 90 percent dimethyl sulfoxide. (b) Sponsor. (c) Conditions of use in horses and dogs Amount Horses. (ii) Dogs. (2) Indications for use. (3) Limitations. [79 FR 10967, Feb. 27, 2014] § 524.770 Doramectin. (a) Specifications. (b) Sponsors. (c) Related tolerances. (d) Special considerations. (e) Conditions of use in cattle Amount. (2) Indications for use. Ostertagia ostertagi Ostertagia ostertagi Ostertagia lyrata Haemonchus placei Trichostrongylus axei Trichostrongylus colubriformis Cooperia oncophora Cooperia punctata Cooperia pectinata Cooperia surnabada Bunostomum phlebotomum Oesophagostomum radiatum Trichuris spp. Dictyocaulus viviparus Thelazia gulosa Thelazia skrjabini Hypoderma bovis Hypoderma lineatum Linognathus vituli Haematopinus eurysternus Solenopotes capillatus Bovicola (Damalinia) bovis Chorioptes bovis Sarcoptes scabiei Haematobia irritans Cooperia oncophora Dictyocaulus viviparus Ostertagia ostertagi Oesophagostomum radiatum Cooperia punctata Haemonchus placei Linognathus vituli Bovicola (Damalinia) bovis (3) Limitations. [69 FR 48392, Aug. 10, 2004, as amended at 70 FR 43046, July 26, 2005; 79 FR 10967, Feb. 27, 2014; 84 FR 32993, July 11, 2019; 87 FR 10970, Feb. 28, 2022; 88 FR 27700, May 3, 2023; 90 FR 6801, Jan. 21, 2025] § 524.775 Emodepside and praziquantel. (a) Specifications. (b) Sponsor. (c) Conditions of use in cats Amount. (2) Indications for use. Ancylostoma tubaeforme Toxocara cati Dipylidium caninum Taenia taeniaeformis (3) Limitations. [72 FR 42291, Aug. 2, 2007, as amended at 86 FR 14820, Mar. 19, 2021] § 524.802 Enrofloxacin and silver sulfadiazine otic emulsion. (a) Specifications. (b) Sponsors. (c) Conditions of use Dogs Amount. (2) Indications for use. (3) Limitations. [65 FR 66620, Nov. 7, 2000, as amended at 79 FR 10967, Feb. 27, 2014; 86 FR 14821, Mar. 19, 2021; 89 FR 85428, Oct. 28, 2024] § 524.814 Eprinomectin. (a) Specifications. (b) Sponsors. (c) Related tolerances. (d) Special considerations. (e) Conditions of use in cattle Amount. (2) Indications for use. Haemonchus placei Ostertagia ostertagi Trichostrongylus axei T. colubriformis T. longispicularis Cooperia oncophora C. punctata C. surnabada Nematodirus helvetianus Bunostomum phlebotomum Oesophagostomum radiatum Strongyloides papillosus Trichuris Dictyocaulus viviparus, Hypoderma lineatum, H. bovis Damalinia bovis, Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus Chorioptes bovis, Sarcoptes scabiei Haematobia irritans D. viviparus H. irritans (3) Limitations. [76 FR 72619, Nov. 25, 2011, as amended at 83 FR 48946, Sept. 28, 2018; 84 FR 39184, Aug. 9, 2019; 88 FR 27700, May 3, 2023; 90 FR 19625, May 9, 2025] § 524.815 Eprinomectin and praziquantel. (a) Specifications. (b) Sponsor. (c) Conditions of use in cats Amount. (2) Indications for use. Dirofilaria immitis, Toxocara cati Ancylostoma tubaeforme; Ancylostoma braziliense Dipylidium caninum Echinococcus multilocularis (3) Limitations. [83 FR 48946, Sept. 28, 2018, as amended at 84 FR 39184, Aug. 9, 2019] § 524.838 Esafoxolaner, eprinomectin, and praziquantel. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. Dirofilaria immitis. Ctenocephalides felis Ixodes scapularis Amblyomma americanum Toxocara cati Ancylostoma tubaeforme; Ancylostoma braziliense Dipylidium caninum (3) Limitations. [88 FR 55566, Aug. 16, 2023] § 524.900 Famphur. (a) Specifications. (b) Sponsor. (c) Special considerations. (d) Related tolerances. (e) Conditions of use Amount. (2) Indications for use in beef and nonlactating dairy cattle. (3) Limitations. [40 FR 13873, Mar. 27, 1975, as amended at 49 FR 34352, Aug. 30, 1984; 57 FR 7652, Mar. 4, 1992; 59 FR 28769, June 3, 1994; 62 FR 55161, Oct. 23, 1997; 62 FR 61626, Nov. 19, 1997; 69 FR 41427, July 9, 2004; 79 FR 10968, Feb. 27, 2014; 83 FR 48946, Sept. 28, 2018] § 524.920 Fenthion. (a) Specifications. (i) 3 percent of fenthion; or (ii) 20 percent fenthion. (2) The drug is a solution containing either 5.6 or 13.8 percent fenthion. Each concentration is available in 2 volumes which are contained in single-dose applicators. (b) Sponsor. (1) No. 058198 for use of product described in paragraph (a)(1)(i) of this section as in paragraph (d)(1) of this section. (2) No. 058198 for use of product described in paragraph (a)(1)(ii) of this section as in paragraph (d)(2) of this section. (3) No. 058198 for use of products described in paragraph (a)(2) of this section as in paragraph (d)(3) of this section. (c) Related tolerances. (d) Conditions of use Beef cattle and nonlactating dairy cattle Amount. (ii) Indications for use. (iii) Limitations. (2) Beef cattle and dairy cattle not of breeding age Amount. (ii) Indications for use. (iii) Limitations. Hypoderma lineatum H. bovis (3) Dogs Amount. (ii) Indications for use. (iii) Limitations. [79 FR 10968, Feb. 27, 2014, as amended at 84 FR 32993, July 11, 2019; 86 FR 14821, Mar. 19, 2021] § 524.955 Florfenicol, terbinafine, and betamethasone acetate otic gel. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. Staphylococcus pseudintermedius Malassezia pachydermatis (3) Limitations. [80 FR 13230, Mar. 13, 2015, as amended at 86 FR 14821, Mar. 19, 2021] § 524.957 Florfenicol, terbinafine, and mometasone otic solution. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. Malassezia pachydermatis Staphylococcus pseudintermedius (3) Limitations. [80 FR 76387, Dec. 9, 2015, as amended at 83 FR 64740, Dec. 18, 2018; 86 FR 14821, Mar. 19, 2021; 88 FR 14901, Mar. 10, 2023; 91 FR 20342, Apr. 16, 2026] § 524.960 Flumethasone, neomycin, and polymyxin B ophthalmic solution. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount Preparation containing hydroxypropyl methylcellulose. (ii) Preparation without hydroxyproply methylcellulose. (2) Indications for use. (3) Limitations. [44 FR 16012, Mar. 16, 1979, as amended at 61 FR 5507, Feb. 13, 1996; 79 FR 10968, Feb. 27, 2013] § 524.970 Flunixin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Amount. (2) Indications for use. (3) Limitations. [83 FR 13635, Mar. 30, 2018, as amended at 88 FR 16549, Mar. 20, 2023] Fluocinolone Topical and Otic Dosage Forms § 524.981 [Reserved] § 524.981a Fluocinolone cream. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13873, Mar. 27, 1975, as amended at 62 FR 40932, July 31, 1997; 79 FR 10968, Feb. 27, 2014] § 524.981b Fluocinolone solution. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use Dogs. (ii) Cats. (3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13873, Mar. 27, 1975, as amended at 62 FR 40932, July 31, 1997; 79 FR 10969, Feb. 27, 2014] § 524.981c Fluocinolone and neomycin cream. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use Dogs. (ii) Dogs and cats. (3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13873, Mar. 27, 1975, as amended at 62 FR 40932, July 31, 1997; 79 FR 10969, Feb. 27, 2014] § 524.981d Fluocinolone and dimethyl sulfoxide solution. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [79 FR 10969, Feb. 27, 2014] § 524.981e Fluocinolone and dimethyl sulfoxide otic solution. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [79 FR 10969, Feb. 27, 2014] § 524.998 Fluralaner. (a) Specifications. (b) Sponsor. (c) Conditions of use Dogs Amount. Amblyomma americanum (ii) Indications for use. Ctenocephalides felis Ixodes scapularis Dermacentor variabilis Rhipicephalus sanguineus A. americanum (iii) Limitations. (2) Cats Amount. D. variabilis (ii) Indications for use. C. felis I. scapularis Haemaphysalis longicornis D. variabilis (iii) Limitations. [81 FR 67152, Sept. 30, 2016, as amended at 82 FR 43485, Sept. 18, 2017; 88 FR 14901, Mar. 10, 2023] § 524.1001 Fluralaner and moxidectin. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. Dirofilaria immitis Toxocara cati, Ancylostoma tubaeforme, Ctenocephalides felis Ixodes scapularis Dermacentor variabilis Haemaphysalis longicornis Amblyomma maculatum (3) Limitations. [85 FR 18120, Apr. 1, 2020, as amended at 87 FR 58963, Sept. 29, 2022; 88 FR 14901, Mar. 10, 2023; 91 FR 41560, July 7, 2026] § 524.1005 Furazolidone powder. (a) Specifications. (b) Sponsors. (2) See No. 017135 for use of the 4 percent product as in paragraph (c)(2)(iv) of this section. (c) Conditions of use Amount. (2) Indications of use Dogs. (ii) Horses. (iii) [Reserved] (iv) Horses and ponies. Staphylococcus aureus, Streptococcus spp. Proteus spp. (3) Limitations. [45 FR 49543, July 25, 1980, as amended at 50 FR 30153, July 24, 1985; 56 FR 50653, Oct. 8, 1991; 57 FR 31314, July 15, 1992; 60 FR 55659, Nov. 2, 1995; 65 FR 41588, July 6, 2000; 79 FR 10969, Feb. 27, 2014; 82 FR 11508, Feb. 24, 2017] § 524.1044 Gentamicin ophthalmic and topical dosage forms. § 524.1044a Gentamicin ophthalmic solution. (a) Specifications. (b) Sponsors. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [80 FR 18776, Apr. 8, 2015, as amended at 89 FR 14410, Feb. 27, 2024] § 524.1044b Gentamicin and betamethasone otic solution. (a) Specifications. (b) Sponsors. (c) Conditions of use Amounts and indications for use. (ii) For the treatment of infected superficial lesions caused by bacteria sensitive to gentamicin in dogs and cats, apply a sufficient amount of the drug to cover the treatment area twice daily for 7 to 14 days. (2) Limitations. [71 FR 13542, Mar. 16, 2006, as amended at 91 FR 41560, July 7, 2026] § 524.1044c Gentamicin ophthalmic ointment. (a) Specifications. (b) Sponsors. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [69 FR 47363, Aug. 5, 2004, as amended at 77 FR 64717, Oct. 23, 2012; 85 FR 4208, Jan. 24, 2020; 88 FR 16549, Mar. 20, 2023] § 524.1044d Gentamicin and betamethasone ointment. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount Otitis externa. (ii) Infected superficial lesions. (2) Indications for use. (3) Limitations. [47 FR 26378, June 18, 1982, as amended at 52 FR 7832, Mar. 13, 1987; 79 FR 10969, Feb. 27, 2014] § 524.1044e Gentamicin spray. (a) Specification. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in cattle Amount. (2) Indications for use. Moraxella bovis. (3) Limitations. Moraxella bovis [48 FR 41157, Sept. 14, 1983, as amended at 52 FR 7833, Mar. 13, 1987; 79 FR 10969, Feb. 27, 2014; 84 FR 32993, July 11, 2019; 88 FR 27700, May 3, 2023] § 524.1044f Gentamicin and betamethasone spray. (a) Specifications. (b) Sponsors. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [71 FR 13542, Mar. 16, 2006, as amended at 72 FR 5929, Feb. 8, 2007; 74 FR 22822, May 15, 2009; 77 FR 3598, Jan. 25, 2012; 88 FR 16549, Mar. 20, 2023; 91 FR 41560, July 7, 2026] § 524.1044g Gentamicin, betamethasone, and clotrimazole ointment. (a) Specifications. (b) Sponsors. (1) No. 000061 for use of 7.5- or 15-gram (g) tubes, 12.5-, 30-, or 215-g bottles. (2) No. 069043 for use of 10-, 20-, 40-, or 215-g bottles. (3) No. 025463 for use of 7.5- or 15-g tubes, or 215-g bottles. (c) Conditions of use in dogs Amount. (i) From 7.5- or 15-g tubes; 10-, 12.5-, or 30-g bottles: 4 drops for dogs weighing less than 30 pounds (lb) or 8 drops for dogs weighing 30 lb or more. (ii) From 20-, 40-, or 215-g bottles: 2 drops for dogs weighing less than 30 lb or 4 drops for dogs weighing 30 lb or more. (ii) From 20- or 215-g bottles: 2 drops for dogs weighing less than 30 lb or 4 drops for dogs weighing 30 lb or more. (2) Indications for use. Malassezia pachydermatis Pityrosporum canis (3) Limitations. [58 FR 38973, July 21, 1993, as amended at 63 FR 31932, June 11, 1998; 68 FR 42970, July 21, 2003; 70 FR 8291, Feb. 18, 2005; 71 FR 13542, Mar. 16, 2006; 71 FR 16481, Apr. 3, 2006; 71 FR 38261, July 6, 2006; 71 FR 56867, Sept. 28, 2006; 78 FR 17597, Mar. 22, 2013; 79 FR 10969, Feb. 27, 2014; 81 FR 17608, Mar. 30, 2016; 91 FR 41560, July 7, 2026] § 524.1044h Gentamicin, mometasone, and clotrimazole otic suspension. (a) Specifications. (b) Sponsors. (c) Conditions of use in dogs Amount. (2) Indications for use. Malassezia pachydermatis Pseudomonas P. aeruginosa Enterococcus faecalis, Proteus mirabilis, (3) Limitations. [66 FR 712, Jan. 4, 2001, as amended at 68 FR 15370, Mar. 31, 2003; 70 FR 36338, June 23, 2005; 79 FR 10969, Feb. 27, 2014; 81 FR 59134, Aug. 29, 2016; 91 FR 20342, Apr. 16, 2026] § 524.1044i Gentamicin and betamethasone ophthalmic solution. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [75 FR 54492, Sept. 8, 2010, as amended at 80 FR 13230, Mar. 13, 2015] § 524.1132 Hydrocortisone, miconazole, and gentamicin otic suspension. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. Malassezia pachydermatis Staphylococcus pseudintermedius (3) Limitations. [76 FR 78150, Dec. 16, 2011, as amended at 83 FR 13635, Mar. 30, 2018] § 524.1140 Imidacloprid and ivermectin. (a) Specifications. (b) Sponsor. (c) Conditions of Use in Dogs Amount. (2) Indications for Use. Dirofilaria immitis Ctenocephalides felis (3) Limitations. [67 FR 78685, Dec. 26, 2002, as amended at 86 FR 14821, Mar. 19, 2021] § 524.1144j Gentamicin, posaconazole, and mometasone furoate otic suspension. (a) Sponsor. (b) Specifications. (c) Conditions of use (1) Amount. (2) Indications for use. (Malassezia pachydermatis) (Staphylococcus pseudintermedius and Pseudomonas aeruginosa)) (3) Limitations. [90 FR 40970, Aug. 22, 2025] § 524.1146 Imidacloprid and moxidectin. (a) Specifications. (1) 100 milligrams (mg) imidacloprid and 25 mg moxidectin; or (2) 100 mg imidacloprid and 10 mg moxidectin. (b) Sponsors. (1) Nos. 017030, 051072, 051311, 055529, 058198, and 061133for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section. (2) Nos. 017030, 051072, 051311, 055529, 058198, and 061133 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section. (3) Nos. 051072, 055529, 058198, 061133, and 061651 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(3) of this section. (c) Special considerations. (d) Conditions of use Dogs Amount. (ii) Indications for use. Dirofilaria immitis Toxocara canis Toxascaris leonina Ancylostoma caninum Uncinaria stenocephala Trichuris vulpis Ctenocephalides felis (B) For treatment of Dirofilaria immitis Sarcoptes scabiei canis. (2) Cats Amount. (ii) Indications for use. Dirofilaria immitis Otodectes cynotis Toxocara cati Ancylostoma tubaeforme Ctenocephalides felis (3) Ferrets Amount. (ii) Indications for use. Dirofilaria immitis Ctenocephalides felis [72 FR 10597, Mar. 9, 2007, as amended at 78 FR 73698, Dec. 9, 2013; 85 FR 18120, Apr. 1, 2020; 86 FR 13185, Mar. 8, 2021; 86 FR 14821, Mar. 19, 2021; 87 FR 17946, Mar. 29, 2022; 87 FR 58963, Sept. 29, 2022; 88 FR 27700, May 3, 2023; 89 FR 14410, Feb. 27, 2024; 90 FR 40970, Aug. 22, 2025] § 524.1193 Ivermectin topical solution. (a) Specifications. (b) Sponsors. (c) Related tolerances. (d) Conditions of use in cattle Amount. (2) Indications for use. Ostertagia ostertagi Haemonchus placei, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. surnabada, Oesophagostomum radiatum Strongyloides papillosus, Trichuris Dictyocaulus viviparus; Hypoderma bovis, H. lineatum; Sarcoptes scabiei bovis; Linognathus vituli, Haematopinus eurysternus, Damalinia bovis, Solenoptes capillatus; Haematobia irritans. O. radiatum D. viviparus C. punctata T. axei O. ostertagi, H. placei, C. oncophora, C. surnabada D. bovis (3) Limitations. [55 FR 50551, Dec. 7, 1990, as amended at 62 FR 38908, July 21, 1997; 62 FR 63271, Nov. 28, 1997; 63 FR 44385, Aug. 19, 1998; 66 FR 13236, Mar. 5, 2001; 66 FR 63165, Dec. 5, 2001; 68 FR 3817, Jan. 27, 2003; 68 FR 4713, Jan. 30, 2003; 69 FR 501, Jan. 6, 2004; 69 FR 62181, Oct. 25, 2004; 71 FR 13542, Mar. 16, 2006; 72 FR 6464, Feb. 12, 2007; 74 FR 36112, July 22, 2009; 75 FR 26648, May 12, 2010; 76 FR 81807, Dec. 29, 2011; 78 FR 17597, Mar. 22, 2013; 78 FR 63872, Oct. 25, 2013; 81 FR 25328, Apr. 28, 2016; 83 FR 13635, Mar. 30, 2018; 84 FR 8974, Mar. 13, 2019; 84 FR 39184, Aug. 9, 2019; 86 FR 13185, Mar. 8, 2021; 88 FR 84701, Dec. 6, 2023; 89 FR 42360, May 15, 2024] § 524.1195 Ivermectin otic suspension. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. Otodectes cynotis (3) Limitations. [66 FR 7578, Jan. 24, 2001, as amended at 74 FR 26782, June 4, 2009] § 524.1200 Kanamycin ophthalmic and topical dosage forms. § 524.1200a Kanamycin ophthalmic ointment. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [79 FR 10969, Feb. 27, 2014] § 524.1200b Kanamycin ophthalmic solution. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [79 FR 10970, Feb. 27, 2014] § 524.1204 Kanamycin, amphomycin, and hydrocortisone ointment. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [79 FR 10970, Feb. 27, 2014] § 524.1240 Levamisole. (a) Specifications. (b) Sponsors. (c) Related tolerances. (d) Conditions of use. Cattle Amount. (2) Indications for use. Haemonchus, Trichostrongylus, Ostertagia Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia Dictyocaulus (3) Limitations. [52 FR 10887, Apr. 6, 1987, as amended at 53 FR 7504, Mar. 9, 1988; 62 FR 61626, Nov. 19, 1997; 67 FR 78355, Dec. 24, 2002; 79 FR 10970, Feb. 27, 2014] § 524.1312 Marbofloxacin, terbinafine, and dexamethasone otic suspension. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (Malassezia pachydermatis) (Staphylococcus pseudintermedius) (3) Limitations. [90 FR 40970, Aug. 22, 2025] § 524.1376 2-Mercaptobenzothiazole solution. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [48 FR 15618, Apr. 12, 1983, as amended at 65 FR 50913, Aug. 22, 2000; 68 FR 33381, June 4, 2003] § 524.1443 Miconazole. (a) Specifications. (2) Each gram of lotion or spray contains miconazole nitrate equivalent to 1 percent miconazole base. (b) Sponsors. (1) No. 000061 for use of cream, lotion, and spray; (2) No. 058829 for use of lotion and spray. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. Microsporum canis Microsporum gypseum Trichophyton mentagrophytes. (3) Limitations. [71 FR 13542, Mar. 16, 2006, as amended at 91 FR 41560, July 7, 2026] § 524.1445 Miconazole, polymixin B, and prednisolone suspension. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. Malassezia pachydermatis Staphylococcus pseudintermedius (3) Limitations. [ 75 FR 4693, Jan. 29, 2010, as amended at 77 FR 46613, Aug. 6, 2012; 81 FR 48703, July 26, 2016] § 524.1446 Milbemycin otic solution. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. Otodectes cynotis (3) Limitations. [65 FR 13905, Mar. 15, 2000, as amended at 66 FR 13849, Mar. 8, 2001] § 524.1448 Mirtazapine transdermal ointment. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [83 FR 64740, Dec. 18, 2018, as amended at 85 FR 45308, July 28, 2020; 88 FR 16549, Mar. 20, 2023] § 524.1450 Moxidectin. (a) Specifications. (1) 5 milligrams (mg) moxidectin (0.5 percent solution). (2) 25 mg moxidectin (2.5 percent solution). (b) Sponsors. (1) No. 058198 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section; and (2) No. 058198 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section. (c) Related tolerances. (d) Conditions of use Cattle Amount. (ii) Indications for use. Ostertagia ostertagi Haemonchus placei Trichostrongylus axei T. colubriformis Cooperia oncophora C. pectinata C. punctata C. spatulata C. surnabada Bunostomum phlebotomum Oesophagostomum radiatum Nematodirus helvetianus Dictyocaulus viviparus Hypoderma bovis, H. lineatum Chorioptes bovis, Psoroptes ovis P. communis bovis Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus, Bovicola Damalinia bovis Haematobia irritans H. placei O. radiatum O. ostertagi D. viviparus (iii) Limitations. (2) Dogs Amount. (ii) Indications for use. Dirofilaria immitis, Ancylostoma caninum Uncinaria stenocephala Toxocara canis Toxascaris leonina Trichuris vulpis (iii) Limitations. [63 FR 14036, Mar. 24, 1998, as amended at 65 FR 36617, June 9, 2000; 66 FR 46370, Sept. 5, 2001. Redesignated at 76 FR 48715, Aug. 9, 2011, as amended at 80 FR 53460, Sept. 4, 2015; 82 FR 21691, May 10, 2017; 86 FR 14821, Mar. 19, 2021] § 524.1465 Mupirocin. (a) Specifications. (b) Sponsors. (c) Conditions of use in dogs Amount. (2) Indications for use. Staphylococcus aureus S. intermedius. (3) Limitations. [72 FR 18119, Apr. 11, 2007, as amended at 75 FR 79296, Dec. 20, 2010; 78 FR 52854, Aug. 27, 2013; 79 FR 10970, Feb. 27, 2014; 82 FR 11508, Feb. 24, 2017] § 524.1484 Neomycin ophthalmic and topical dosage forms. § 524.1484b Neomycin, isoflupredone, and tetracaine powder. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses, dogs, and cats Amount. (2) Indications for use. (3) Limitations. [40 FR 13873, Mar. 27, 1975, as amended at 43 FR 18172, Apr. 28, 1978; 79 FR 10970, Feb. 27, 2014; 85 FR 45308, July 28, 2020] § 524.1484c Neomycin, isoflupredone, and tetracaine ointment. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [40 FR 13873, Mar. 27, 1975, as amended at 43 FR 18172, Apr. 28, 1978; 79 FR 10970, Feb. 27, 2014] § 524.1484d Neomycin, hydrocortisone, and tetracaine otic ointment. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [40 FR 13873, Mar. 27, 1975, as amended at 49 FR 21922, May 24, 1984; 79 FR 10970, Feb. 27, 2014] § 524.1484e Neomycin and polymyxin B ophthalmic solution. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [40 FR 13873, Mar. 27, 1975, as amended at 61 FR 5507, Feb. 13, 1996; 79 FR 10970, Feb. 27, 2014] § 524.1484f Neomycin, prednisolone, and tetracaine otic suspension. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [40 FR 13873, Mar. 27, 1975, as amended at 79 FR 10971, Feb. 27, 2014] § 524.1484g Neomycin, thiabendazole, and dexamethasone solution. (a) Specifications. (b) Sponsors. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [40 FR 13873, Mar. 27, 1975, as amended at 62 FR 63271, Nov. 28, 1997; 79 FR 10971, Feb. 27, 2014; 80 FR 61297, Oct. 13, 2015; 84 FR 39184, Aug. 9, 2019; 88 FR 16549, Mar. 20, 2023] § 524.1484h Neomycin, penicillin, polymyxin B, and hydrocortisone suspension. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. (d) Conditions of use—dogs Amount. (2) Indications for use. (3) Limitations. [59 FR 5105, Feb. 3, 1994, as amended at 79 FR 10971, Feb. 27, 2014] § 524.1484i Neomycin and hydrocortisone ointment. (a) Specifications. 1 (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [43 FR 40456, Sept. 12, 1978, as amended at 79 FR 10971, Feb. 27, 2014] § 524.1484k Neomycin and prednisolone suspension. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [79 FR 10971, Feb. 27, 2014] § 524.1580 Nitrofurazone topical dosage forms. § 524.1580a Nitrofurazone ointment. (a) Specifications. (b) Sponsors. (1) See Nos. 058005, 059051, 061133, and 069043 for use on dogs, cats, or horses. (2) See No. 017135 for use on dogs and horses. (3) See Nos. 017153 and 058829 for use on horses. (c) [Reserved] (d) Conditions of use Amount. (2) Indications for use. (3) Limitations. [46 FR 43402, June 27, 1980. Redesignated at 79 FR 10971, Feb. 27, 2014] Editorial Note: For Federal Register www.govinfo.gov. § 524.1580b Nitrofurazone soluble powder. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [45 FR 43402, June 27, 1980, as amended at 47 FR 43368, Oct. 1, 1982; 48 FR 28984, June 24, 1983; 53 FR 40728, Oct. 18, 1988; 54 FR 30542, July 21, 1989; 56 FR 50653, Oct. 8, 1991; 59 FR 33197, June 28, 1994; 60 FR 55659, Nov. 2, 1995; 62 FR 35077, June 30, 1997; 76 FR 17778, Mar. 31, 2011; 78 FR 21060, Apr. 9, 2013. Redesignated at 79 FR 10971, Feb. 27, 2014, as amended at 79 FR 64117, Oct. 28, 2014; 83 FR 48947, Sept. 28, 2018] § 524.1600 Nystatin ophthalmic and topical dosage forms. § 524.1600a Nystatin, neomycin, thiostrepton, and triamcinolone ointment. (a) Specifications. (b) Sponsors. (1) For petrolatum base ointments: Nos. 025463 and 054771; or (2) For vanishing cream base ointments: Nos. 025463 and 054771. (c) Conditions of use Amount. (ii) For otic use: Clean ear canal of impacted cerumen, remove any foreign bodies such as grass awns and ticks, and instill three to five drops of petrolatum base ointment. Preliminary use of a local anesthetic may be advisable. (iii) For infected anal glands and cystic areas: Drain gland or cyst and fill with petrolatum base ointment. (2) Indications for use. Candida albicans (ii) Otitis, cysts, and anal gland infections: Use petrolatum base ointment in dogs and cats for the treatment of acute and chronic otitis and interdigital cysts, and in dogs for anal gland infections. (3) Limitations. [40 FR 13873, Mar. 27, 1975, as amended at 43 FR 29770, July 11, 1978; 50 FR 41490, Oct. 11, 1985; 53 FR 39257, Oct. 6, 1988; 54 FR 5431, Feb. 3, 1989; 54 FR 48090, Nov. 21, 1989; 56 FR 50653, Oct. 8, 1991; 60 FR 55660, Nov. 2, 1995; 61 FR 63712, Dec. 2, 1996; 64 FR 42831, Aug. 6, 1999; 67 FR 67521, Nov. 6, 2002; 68 FR 55201, Sept. 23, 2003; 70 FR 50183, Aug. 26, 2005; 71 FR 13542, Mar. 16, 2006; 79 FR 10972, Feb. 27, 2014; 88 FR 84701, Dec. 6, 2023] § 524.1600b Nystatin, neomycin, thiostrepton, and triamcinolone ophthalmic ointment. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Dogs and cats Amount. (ii) Indications for use. Candida albicans (iii) Limitations. (2) Cattle Amount. (ii) Indications for use. (iii) Limitations. [40 FR 13873, Mar. 27, 1975, as amended at 50 FR 41490, Oct. 11, 1985; 79 FR 10972, Feb. 27, 2014; 84 FR 32993, July 11, 2019] § 524.1610 Orbifloxacin, mometasone furoate monohydrate, and posaconazole suspension. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. Malassezia pachydermatis Pseudomonas aeruginosa Enterococcus faecalis (3) Limitations. [75 FR 16346, Apr. 1, 2010] § 524.1662 Oxytetracycline ophthalmic and topical dosage forms. § 524.1662a Oxytetracycline and hydrocortisone spray. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [40 FR 13873, Mar. 27, 1975, as amended at 79 FR 10972, Feb. 27, 2014] § 524.1662b Oxytetracycline and polymyxin B ophthalmic ointment. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. E. coli, A. aerogenes (3) Limitations. [40 FR 13873, Mar. 27, 1975, as amended at 79 FR 10972, Feb. 27, 2014; 88 FR 14901, Mar. 10, 2023] § 524.1742 Phosmet emulsifiable liquid. (a) Specifications. N- S O,O- (b) Sponsor. (c) Related tolerances. (d) Conditions of use Methods of application. Table 1 to Paragraph ( d To control/method of use Dilution rate (gal. drug: gal. of water) Grubs: Dip 1:60 Pour-on 1:2 Spray 1:49 Lice: Dip 1:60 Pour-on 1:2 or 1:5 Spray 1:49 or 1:100 Hornflies: Dip 1:60 Spray 1:49 or 1:100 Cattle Ticks: Dip 1:60 or 1:240 Spray 1:49 Southern cattle ticks: Dip 1:60 or 1:240 Spray 1:49 Scabies mites: Dip 1:60 Lone Star Ticks: Dip 1:60 Spray 1:49 or 1:100 (i) Dip vat procedure. 1/8 1/4 (B) Dip maintenance. 1 ( 2 (ii) Spray method. (iii) Pour-on method. (2) Timing of applications for cattle grub control. (3) Treatment regimens. (ii) Control of Lone Star Ticks and hornflies requires two treatments, 7 days apart. (4) Warnings. [40 FR 13873, Mar. 27, 1975, as amended at 46 FR 27914, May 22, 1981; 48 FR 39607, Sept. 1, 1983; 54 FR 51021, Dec. 12, 1989; 61 FR 8873, Mar. 6, 1996; 62 FR 61626, Nov. 19, 1997; 63 FR 5255, Feb. 2, 1998; 85 FR 18120, Apr. 1, 2020] § 524.1982 Proparacaine ophthalmic solution. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (i) For removal of sutures: Instill one to two drops 2 or 3 minutes before removal of stitches. (ii) For removal of foreign bodies from eye, ear, and nose: For ophthalmic use, instill three to five drops in the eye prior to examination; for otic use, instill five to ten drops in the ear; for nasal use, instill five to ten drops in each nostril every 3 minutes for three doses. (iii) For tonometry: Instill one to two drops immediately before measurement. (iv) As an aid in treatment of otitis: Instill two drops into the ear every 5 minutes for three doses. (v) For minor surgery: Instill one or more drops as required. (vi) For catheterization: Instill two to three drops with a blunt 20-gauge needle immediately before inserting catheter. (2) Indications for use. (3) Limitations. (d) Conditions of use. (2) It is administered as follows: (i) For removal of sutures: Instill one to two drops 2 or 3 minutes before removal of stitches. (ii) For removal of foreign bodies from eye, ear, and nose: For ophthalmic use, instill three to five drops in the eye prior to examination; for otic use, instill five to 10 drops in the ear; for nasal use, instill five to 10 drops in each nostril every 3 minutes for three doses. (iii) For tonometry: Instill one to two drops immediately before measurement. (iv) As an aid in treatment of otitis: Instill two drops into the ear every 5 minutes for three doses. (v) For minor surgery: Instill one or more drops as required. (vi) For catheterization: Instill two to three drops with a blunt 20-gauge needle immediately before inserting catheter. (3) For use only by or on the order of a licensed veterinarian. [40 FR 13873, Mar. 27, 1975, as amended at 50 FR 41490, Oct. 11, 1985; 79 FR 10972, Feb. 27, 2014] § 524.2080 Ropinirole. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. 2 2 (2) Indications for use. (3) Limitations. [86 FR 13185, Mar. 8, 2021] § 524.2098 Selamectin. (a) Specifications. (b) Sponsors. (c) Conditions of use Amount. (2) Indications for use. Ctenocephalides felis Dirofilaria immitis, Otodectes cynotis Sarcoptes scabiei Dermacentor variabilis Ancylostoma tubaeforme Toxocara cati (3) Limitations. [64 FR 37401, July 12, 1999, as amended at 64 FR 48707, Sept. 8, 1999; 65 FR 45282, July 21, 2000; 74 FR 19878, Apr. 30, 2009; 79 FR 10972, Feb. 27, 2014; 86 FR 17064, Apr. 1, 2021; 87 FR 58963, Sept. 29, 2022; 89 FR 14410, Feb. 27, 2024; 89 FR 42360, May 15, 2024] § 524.2099 Selamectin and sarolaner. (a) Specifications. (b) Sponsor. (c) Conditions of use in cats Amount. (2) Indications for use. Dirofilaria immitis, Toxocara cati Ancylostoma tubaeforme Otodectes cynotis Ctenocephalides felis Dipylidium caninum Ctenocephalides felis Amblyomma americanum Amblyomma maculatum Dermacentor variabilis Ixodes scapularis (3) Limitations. [84 FR 12494, Apr. 2, 2019, as amended at 89 FR 14410, Feb. 27, 2024; 90 FR 6801, Jan. 21, 2025] § 524.2101 Selenium disulfide suspension. (a) Specifications. (b) Sponsors. (c) Conditions of use on dogs Indications for use. (2) Amount. (3) Limitations. [47 FR 53351, Nov. 26, 1982, as amended at 48 FR 32762, July 19, 1983; 54 FR 36962, Sept. 6, 1989; 56 FR 9623, Mar. 7, 1991; 58 FR 41025, Aug. 2, 1993; 63 FR 26981, May 15, 1998; 70 FR 50183, Aug. 26, 2005; 84 FR 39184, Aug. 9, 2019; 88 FR 27700, May 3, 2023] § 524.2338 Terbinafine and betamethasone acetate. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. Malassezia pachydermatis (3) Limitations. [89 FR 42360, May 15, 2024] § 524.2350 Tolnaftate cream. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. Microsporum canis Microsporum gypseum. (3) Limitations. [79 FR 10972, Feb. 27, 2014] § 524.2482 Triamcinolone spray. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [68 FR 4916, Jan. 31, 2003, as amended at 78 FR 17868, Mar. 25, 2013] § 524.2620 Liquid crystalline trypsin, Peru balsam, castor oil. (a) Specifications. (2) Each gram of liquid or aerosol contains 0.1 milligram of crystalline trypsin, 72.5 milligrams of Peru balsam, and 800 milligrams of castor oil. (b) Sponsors. (1) No. 069043 for use of product described in paragraph (a)(1). (2) No. 017135 for use of product described in paragraph (a)(2). (c) Conditions of use Amount. (2) Indications for use. [79 FR 10973, Feb. 27, 2014, as amended at 88 FR 14901, Mar. 10, 2023]