[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: 21CFR347.10]

[Page 266-267]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 347--SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
                   Subpart A--Astringent Drug Products
 
Sec. 347.10  Astringent active ingredients.

    The active ingredient of the product consists of any one of the 
following within the specified concentration established for each 
ingredient:
    (a) Aluminum acetate, 0.13 to 0.5 percent (depending on the 
formulation and concentration of the marketed product, the manufacturer 
must provide adequate directions so that the resulting solution to be 
used by the consumer contains 0.13 to 0.5 percent aluminum acetate).

[[Page 267]]

    (b) Aluminum sulfate, 46 to 63 percent (the concentration is based 
on the anhydrous equivalent).
    (c) Witch hazel.

[58 FR 54462, Oct. 21, 1993, as amended at 59 FR 28768, June 3, 1994]