---
kind: "section"
citation: "21 C.F.R. § 524.957"
title: "21"
number: "524.957"
heading: "Florfenicol, terbinafine, and mometasone otic solution."
url: "https://uscodex.org/cfr/21/524.957"
---

# §524.957. Florfenicol, terbinafine, and mometasone otic solution.

- (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)](/cfr/21/510.600.md?p=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.

## Notes

### 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]