21 CFR § 524.802 - Enrofloxacin and silver sulfadiazine otic emulsion.

---
identifier: "/us/cfr/t21/s524.802"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.802 - Enrofloxacin and silver sulfadiazine otic emulsion."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.802"
section_name: "Enrofloxacin and silver sulfadiazine otic emulsion."
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"
---


# 524.802 Enrofloxacin and silver sulfadiazine otic emulsion.

(a) *Specifications.* Each milliliter contains 5 milligrams (mg) enrofloxacin and 10 mg silver sulfadiazine.

(b) *Sponsors.* See Nos. 058198 and 069043 in § 510.600(c) of this chapter.

(c) *Conditions of use*—*Dogs*—(1) *Amount.* 5 to 10 drops for dogs weighing 35 pounds (lb) or less and 10 to 15 drops for dogs weighing more than 35 lb; applied twice daily for up to 14 days.

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

(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.

[65 FR 66620, Nov. 7, 2000, as amended at 79 FR 10967, Feb. 27, 2014; 86 FR 14821, Mar. 19, 2021; 89 FR 85428, Oct. 28, 2024]