21 CFR 524.957
§ 524.957 Florfenicol, terbinafine, and mometasone otic solution.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 524.957, § 524.957 Florfenicol, terbinafine, and mometasone otic solution, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87589
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Full text
(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 Nos. 017030, 051072, 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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.