21 CFR § 524.1484b - Neomycin, isoflupredone, and tetracaine powder.

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


# 524.1484b Neomycin, isoflupredone, and tetracaine powder.

(a) *Specifications.* Each 15-gram insufflator bottle contains 5 milligrams (mg) neomycin sulfate (equivalent to 3.5 mg neomycin base), 1 mg isoflupredone acetate, and 5 mg tetracaine hydrochloride in a powder base.

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

(c) *Conditions of use in horses, dogs, and cats*—(1) *Amount.* Apply to affected areas as a dusting powder.

(2) *Indications for use.* For the treatment or as adjunctive therapy of certain ear and skin conditions caused by or associated with neomycin-susceptible organisms and/or allergy; as a superficial dressing applied to minor cuts, wounds, lacerations, abrasions, and for postsurgical application where reduction of pain and inflammatory response is deemed desirable; as a dusting powder following amputation of tails, claws, and dewclaws and following ear trimming, castrating, and such surgical procedures as ovariohysterectomies. For the treatment of acute otitis externa, acute moist dermatitis, and interdigital dermatitis in dogs.

(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; 85 FR 45308, July 28, 2020]