[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR524.802]

[Page 297]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  524.802  Enrofloxacin, silver sulfadiazine emulsion.

    (a) Specifications. Each milliliter contains 5 milligrams (mg) 
enrofloxacin and 10 mg silver sulfadiazine.
    (b) Sponsor. See No. 000859 in Sec.  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 extra-label 
use of this drug in food-producing animals.

[65 FR 66620, Nov. 7, 2000]