- (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.
[80 FR 76387, Dec. 9, 2015, as amended at 83 FR 64740, Dec. 18, 2018; 86 FR 14821, Mar. 19, 2021; 88 FR 14901, Mar. 10, 2023; 91 FR 20342, Apr. 16, 2026]