[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR346.16]

[Page 270]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 346_ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of 
 
                      Subpart B_Active Ingredients
 
Sec.  346.16  Analgesic, anesthetic, and antipruritic active ingredients.

    The active ingredient of the product consists of any of the 
following when used within the concentration range established for each 
ingredient:
    (a) Camphor 0.1 to 3 percent.
    (b) Juniper tar 1 to 5 percent.
    (c) Menthol 0.1 to 1 percent.