21 CFR § 524.1445 - Miconazole, polymixin B, and prednisolone suspension.

---
identifier: "/us/cfr/t21/s524.1445"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.1445 - Miconazole, polymixin B, and prednisolone suspension."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.1445"
section_name: "Miconazole, polymixin B, and prednisolone 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"
---


# 524.1445 Miconazole, polymixin B, and prednisolone suspension.

(a) *Specifications.* Each milliliter of suspension contains 23 milligrams (mg) miconazole nitrate, 0.5293 mg polymixin B sulfate, and 5 mg prednisolone acetate.

(b) *Sponsor.* See No. 058198 in § 510.600(c) of this chapter.

(c) *Conditions of use in dogs*—(1) *Amount.* Instill five drops in the ear canal twice daily for 7 consecutive days.

(2) *Indications for use.* For the treatment of canine otitis externa 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.

[ 75 FR 4693, Jan. 29, 2010, as amended at 77 FR 46613, Aug. 6, 2012; 81 FR 48703, July 26, 2016]