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Electronic Code of Federal Regulations

e-CFR data is current as of December 11, 2019

Title 21Chapter ISubchapter EPart 524 → §524.802


Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS


§524.802   Enrofloxacin and silver sulfadiazine otic emulsion.

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

(b) Sponsor. See No. 000859 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]

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