Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024
§ 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 useDogs—(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]
authority: 21 U.S.C. 360b.
source: 40 FR 13873, Mar. 27, 1975, unless otherwise noted.
cite as: 21 CFR 524.802