21 C.F.R. § 524.802

Current through September 30, 2024
Section 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. 058198 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.

21 C.F.R. §524.802

65 FR 66620, Nov. 7, 2000, as amended at 79 FR 10967, Feb. 27, 2014; 86 FR 14821, Mar. 19, 2021
86 FR 14821, 3/19/2021