21 CFR § 524.1312 - Marbofloxacin, terbinafine, and dexamethasone otic suspension.

---
identifier: "/us/cfr/t21/s524.1312"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.1312 - Marbofloxacin, terbinafine, and dexamethasone otic suspension."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.1312"
section_name: "Marbofloxacin, terbinafine, and dexamethasone otic suspension."
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"
---


# 524.1312 Marbofloxacin, terbinafine, and dexamethasone otic suspension.

(a) *Specifications.* Each single-use tube contains 15.1 milligrams (mg) marbofloxacin, 22.7 mg terbinafine, and 2.01 mg dexamethasone.

(b) *Sponsor.* See No. 043264 in § 510.600(c) of this chapter.

(c) *Conditions of use*—(1) *Amount.* Administer one dose (1 tube) per affected ear once. Do not clean the ear canal for 30 days after administration.

(2) *Indications for use.* For the treatment of otitis externa associated with susceptible strains of yeast *(Malassezia pachydermatis)* and bacteria *(Staphylococcus pseudintermedius)* in dogs.

(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[90 FR 40970, Aug. 22, 2025]