§524.957. Florfenicol, terbinafine, and mometasone otic solution.
21 C.F.R. § 524.957
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.
Sponsor. See Nos. 017030, 051072, and 058198 in § 510.600(c) of this chapter.
Conditions of use in dogs—
Amount. Administer one dropperette (1 mL) per affected ear(s).
Indications for use. For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Notes, amendments, and revision history
Amendments
[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]
Authority
Authority: 21 U.S.C. 360b.
Source
Source: 40 FR 13873, Mar. 27, 1975, unless otherwise noted.
Amendments
[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]