21 CFR 524.2338
§ 524.2338 Terbinafine and betamethasone acetate.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 524.2338, § 524.2338 Terbinafine and betamethasone acetate, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87656
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.