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. [80 FR 13230, Mar. 13, 2015, as amended at 86 FR 14821, Mar. 19, 2021]