21 CFR § 524.1484d - Neomycin, hydrocortisone, and tetracaine otic ointment.

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


# 524.1484d Neomycin, hydrocortisone, and tetracaine otic ointment.

(a) *Specifications.* The product contains 5 milligrams of neomycin sulfate, equivalent to 3.5 milligrams of neomycin base, 5 milligrams of hydrocortisone 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 and cats*—(1) *Amount.* Instill a quantity of ointment sufficient to fill the external ear canal; may be applied one to three times daily.

(2) *Indications for use.* For the treatment of ear canker and other inflammatory conditions of the external ear canal, acute otitis externa and, to a lesser degree, chronic otitis externa.

(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 49 FR 21922, May 24, 1984; 79 FR 10970, Feb. 27, 2014]