21 CFR 524.802
§ 524.802 Enrofloxacin and silver sulfadiazine otic emulsion.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 524.802, § 524.802 Enrofloxacin and silver sulfadiazine otic emulsion, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87582
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.