21 CFR § 524.957 - Florfenicol, terbinafine, and mometasone otic solution.

---
identifier: "/us/cfr/t21/s524.957"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.957 - Florfenicol, terbinafine, and mometasone otic solution."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.957"
section_name: "Florfenicol, terbinafine, and mometasone otic solution."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "524"
part_name: "OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13873, Mar. 27, 1975, unless otherwise noted."
cfr_part: "524"
---


# 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 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]