21 CFR § 524.955
Florfenicol, terbinafine, and betamethasone acetate otic gel
June 25, 2020
(a) Specifications. Each milliliter of gel contains 10 milligrams (mg) florfenicol, 10 mg terbinafine, and 1 mg betamethasone acetate.
(b) Sponsor. See No. 058198 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 bacteria (Staphylococcus pseudintermedius) and yeast (Malassezia pachydermatis).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[80 FR 13230, Mar. 13, 2015]
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