[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: 21CFR524.155]

[Page 293-294]
 
                        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.  524.155  Bacitracin zinc-polymyxin B sulfate-neomycin sulfate-hydrocortisone or hydrocortisone acetate ophthalmic ointment.

    (a) Sponsor. To firms identified in Sec.  510.600(c) of this chapter 
as follows:
    (1) To 000061; each gram of ointment contains 400 units of 
bacitracin zinc, 10,000 units of polymyxin B sulfate, 5 milligrams of 
neomycin sulfate (equivalent to 3.5 milligrams of neomycin base), and 10 
milligrams of hydrocortisone.
    (2) To 025463; each gram of ointment contains 400 units of 
bacitracin zinc, 10,000 units of polymyxin B sulfate, 5 milligrams of 
neomycin sulfate (equivalent to 3.5 milligrams of neomycin base), and 10 
milligrams of hydrocortisone acetate.
    (b) Conditions of use. Dogs and cats. (1) Amount. Apply a thin film 
over the cornea three or four times daily.
    (2) Indications for use. For treating acute or chronic 
conjunctivitis caused by susceptible organisms.
    (3) Limitations. All topical ophthalmic preparations containing 
corticosteroids with or without an antimicrobial agent are 
contraindicated in the initial treatment of corneal ulcers. They should 
not be used until the infection is under control and corneal 
regeneration is well underway. Federal law restricts

[[Page 294]]

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 61626, Nov. 19, 1997]