21 C.F.R. § 524.955

Current through May 31, 2024
Section 524.955 - Florfenicol, terbinafine, and betamethasone acetate otic gel
(a)Specifications. Each milliliter of gel contains 10 milligrams (mg) florfenicol, 10 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 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.

21 C.F.R. §524.955

80 FR 13230, Mar. 13, 2015, as amended at 86 FR 14821, Mar. 19, 2021
86 FR 14821, 3/19/2021