[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR333.110]

[Page 217]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 333--TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
              Subpart B--First Aid Antibiotic Drug Products
 
Sec. 333.110  First aid antibiotic active ingredients.

    The product consists of any of the following active ingredients 
within the specified concentration established for each ingredient and 
in the specified dosage form:
    (a) Bacitracin ointment containing, in each gram, 500 units of 
bacitracin in a suitable ointment base.
    (b) Bacitracin zinc ointment containing, in each gram, 500 units of 
bacitracin zinc in a suitable ointment base.
    (c) Chlortetracycline hydrochloride ointment containing, in each 
gram, 30 milligrams of chlortetracycline hydrochloride in a suitable 
ointment base.
    (d) Neomycin sulfate ointment containing, in each gram, 3.5 
milligrams of neomycin in a suitable water soluble or oleaginous 
ointment base.
    (e) Neomycin sulfate cream containing, in each gram, 3.5 milligrams 
of neomycin in a suitable cream base.
    (f) Tetracycline hydrochloride ointment containing, in each gram, 30 
milligrams of tetracycline hydrochloride in a suitable ointment base.

[52 FR 47322, Dec. 11, 1987, as amended at 53 FR 18838, May 25, 1988; 64 
FR 403, Jan. 5, 1999]