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Code of Federal Regulations (Last Updated: July 5, 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 |
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Fluocinolone Topical and Otic Dosage Forms |
§ 524.2338 - Terbinafine and betamethasone acetate.
Latest version.
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§ 524.2338 Terbinafine and betamethasone acetate.
(a) Specifications. Each milliliter of gel contains 10 milligrams (mg) terbinafine and 1 mg betamethasone acetate.
(b) Sponsor. See No. 043264 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —
(1) Amount. Administer one dose (1 tube) per affected ear(s) and repeat administration in 7 days.
(2) Indications for use. For the treatment of otitis externa in dogs, associated with susceptible strains of yeast (Malassezia pachydermatis).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[89 FR 42360, May 15, 2024]