[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR524.321]

[Page 291]
 
                        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. 524.321  Cephalonium, polymyxin B sulfate, flumethasone, iodochlorhy-droxyquin, piperocaine hydrochloride topical-otic ointment.

    (a) Specifications. Each gram of the drug contains 10 milligrams 
cephalonium, 5,000 units polymyxin B sulfate, 0.25 milligram 
flumethasone, 30 milligrams iodochlorhydroxyquin, and 40 milligrams 
piperocaine hydrochloride in a suitable and harmless ointment base.
    (b) Sponsor. See No. 000986 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. The drug is recommended for dermal and otic 
use on dogs and cats for the treatment of the following conditions when 
complicated by bacteria, yeast, or fungus: Pyodermatitis, allergic 
dermatitis, dermatophytosis, nonspecific pruritus, and external otitis. 
For mild inflammations a periodic treatment of applying from once daily 
to twice weekly may be indicated. In severe conditions apply once or 
twice daily when continuous treatment may be indicated. Dosage per 
treatment should not exceed 300 milligrams of the ointment. For otic use 
treatment should not exceed a total of 12 days. For use only by or on 
the order of a licensed veterinarian.