[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: 21CFR346.18]

[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.  346.18  Astringent 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) Calamine, within a concentration range of 5 to 25 percent by 
weight per dosage unit (based on the zinc oxide content of calamine).
    (b) Witch hazel, 10 to 50 percent.
    (c) Zinc oxide, within a concentration range of 5 to 25 percent by 
weight per dosage unit.

[55 FR 31779, Aug. 3, 1990, as amended at 59 FR 28767, June 3, 1994]