[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: 21CFR333.210]

[Page 220-221]
 
                        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 C--Topical Antifungal Drug Products
 
Sec. 333.210  Antifungal active ingredients.

    The active ingredient of the product consists of any one of the 
following within the specified concentration established for each 
ingredient:
    (a) Clioquinol 3 percent.
    (b) Haloprogin 1 percent.
    (c) Miconazole nitrate 2 percent.
    (d) Povidone-iodine 10 percent.
    (e) Tolnaftate 1 percent.
    (f) Undecylenic acid, calcium undecylenate, copper undecylenate, and 
zinc undecylenate may be used individually or in any ratio that provides 
a total undecylenate concentration of 10 to 25 percent.

[[Page 221]]

    (g) Clotrimazole 1 percent.

[58 FR 49898, Sept. 23, 1993, as amended at 67 FR 5943, Feb. 8, 2002]