[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: 21CFR524.154]

[Page 293]
 
                        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.  524.154  Bacitracin or bacitracin zinc-neomycin sulfate-polymyxin B sulfate ophthalmic ointment.

    (a) Sponsor. To firms identified in Sec.  510.600(c) of this chapter 
as follows:
    (1) To 000009; each gram contains 500 units of bacitracin, 3.5 
milligrams of neomycin, and 10,000 units of polymyxin B.
    (2) To 000061 and 025463; each gram contains 400 units of bacitracin 
zinc, 3.5 milligrams of neomycin, and 10,000 units of polymyxin B 
sulfate.
    (b) Conditions of use. Dogs and Cats. (1) Amount. Apply a thin film 
over the cornea 3 or 4 times daily.
    (2) Indications for use. Treatment of superficial bacterial 
infections of the eyelid and conjunctiva of dogs and cats when due to 
susceptible organisms.
    (3) Limitations. Laboratory tests should be conducted including in 
vitro culturing and susceptibility tests on samples collected prior to 
treatment. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.

[57 FR 37333, Aug. 18, 1992, as amended at 61 FR 8873, Mar. 6, 1996; 62 
FR 61625, Nov. 19, 1997]