21 CFR § 524.1132 - Hydrocortisone, miconazole, and gentamicin otic suspension.

---
identifier: "/us/cfr/t21/s524.1132"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.1132 - Hydrocortisone, miconazole, and gentamicin otic suspension."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.1132"
section_name: "Hydrocortisone, miconazole, and gentamicin 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"
---


# 524.1132 Hydrocortisone, miconazole, and gentamicin otic suspension.

(a) *Specifications.* Each milliliter (mL) of suspension contains 1.11 milligrams (mg) hydrocortisone aceponate, 17.4 mg miconazole nitrate, and 1.5 mg gentamicin (as gentamicin sulfate).

(b) *Sponsor.* See No.051311 in § 510.600(c) of this chapter.

(c) *Conditions of use in dogs*—(1) *Amount.* Instill 1.0 mL in the affected ear once daily for 5 days.

(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.

[76 FR 78150, Dec. 16, 2011, as amended at 83 FR 13635, Mar. 30, 2018]