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Code of Federal Regulations (Last Updated: October 10, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter E - Animal Drugs, Feeds, and Related Products |
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Part 524 - Ophthalmic and Topical Dosage Form New Animal Drugs |
§ 524.957 - Florfenicol, terbinafine, and mometasone otic solution.
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§ 524.957 Florfenicol, terbinafine, and mometasone otic solution.
(a) Specifications. Each single-dose, prefilled dropperette contains 1 milliliter (mL) of a solution containing 16.6 milligrams (mg) florfenicol, 14.8 mg terbinafine (equivalent to 16.6 mg terbinafine hydrochloride), and 2.2 mg mometasone furoate.
(b) Sponsor. See NoNos. 017030 and 058198 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs -
(1) Amount. Administer one dropperette (1 mL) per affected ear(s).
(2) Indications for use. For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[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]