21 CFR § 524.1484c - Neomycin, isoflupredone, and tetracaine ointment.

---
identifier: "/us/cfr/t21/s524.1484c"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.1484c - Neomycin, isoflupredone, and tetracaine ointment."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.1484c"
section_name: "Neomycin, isoflupredone, and tetracaine ointment."
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"
---


# 524.1484c Neomycin, isoflupredone, and tetracaine ointment.

(a) *Specifications.* The drug contains 5 milligrams of neomycin sulfate (equivalent to 3.5 milligrams of neomycin base), 1 milligram of isoflupredone acetate, and 5 milligrams of tetracaine hydrochloride in each gram of ointment.

(b) *Sponsor.* See No. 054771 in § 510.600(c) of this chapter.

(c) *Conditions of use in dogs*—(1) *Amount.* In treatment of otitis externa and other inflammatory conditions of the external ear canal, a quantity of ointment sufficient to fill the external ear canal; may be applied one to three times daily. When used on the skin or mucous membranes, the affected area should be cleansed, and a small amount of the ointment applied and spread or rubbed in gently. The involved area may be treated one to three times a day and these daily applications continued in accordance with the clinical response.

(2) *Indications for use.* For the treatment of acute otitis externa in dogs and to a lesser degree, chronic otitis externa in dogs. It also is effective in treating anal gland infections and moist dermatitis in the dog and is a useful dressing for minor cuts, lacerations, abrasions, and post-surgical therapy in the horse, cat, and dog. It may also be used following amputation of dewclaws, tails and claws, following ear trimming and castrating operations.

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

[40 FR 13873, Mar. 27, 1975, as amended at 43 FR 18172, Apr. 28, 1978; 79 FR 10970, Feb. 27, 2014]