§ 524.955 Florfenicol, terbinafine, and betamethasone acetate otic gel.
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Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.
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Specifications.(a) Each milliliter of gel contains 10 milligrams (mg) florfenicol, 10 mg terbinafine, and 1 mg betamethasone acetate.
Sponsor.(b) See No. 043264 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer one dose (1 tube) per affected ear(s) and repeat administration in 7 days.
Indications for use.Staphylococcus pseudintermediusMalassezia pachydermatis(2) For the treatment of otitis externa in dogs associated with susceptible strains of bacteria () and yeast ().
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[80 FR 13230, Mar. 13, 2015, as amended at 86 FR 14821, Mar. 19, 2021]
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