21 CFR § 524.1484f - Neomycin, prednisolone, and tetracaine otic suspension.

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


# 524.1484f Neomycin, prednisolone, and tetracaine otic suspension.

(a) *Specifications.* The product contains 5 milligrams of neomycin sulfate equivalent to 3.5 milligrams of neomycin base, 2.5 milligrams of prednisolone acetate, and 5 milligrams of tetracaine hydrochloride in each milliliter of sterile suspension.

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

(c) *Conditions of use in dogs and cats*—(1) *Amount.* Instill 2 to 6 drops in the external ear canal 2 or 3 times daily.

(2) *Indications for use.* For the treatment of acute otitis externa and, to a lesser degree, chronic otitis externa; as treatment or adjunctive therapy of certain ear conditions caused by or associated with neomycin-susceptible organisms and/or allergy.

(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 79 FR 10971, Feb. 27, 2014]