[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR350.60]

[Page 290]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 350_ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN
USE--Table of Contents
 
             Subpart D_Guidelines for Effectiveness Testing
 
Sec. 350.60  Guidelines for effectiveness testing of antiperspirant
drug products.


    An antiperspirant in finished dosage form may vary in degree of 
effectiveness because of minor variations in formulation. To assure the 
effectiveness of an antiperspirant, the Food and Drug Administration is 
providing guidelines that manufacturers may use in testing for 
effectiveness. These guidelines are on file in the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. These guidelines are available on the FDA's 
Web site at http://www.fda.gov/cder/otc/index.htm or on request for a 
nominal charge by submitting a Freedom of Information (FOI) request in 
writing to FDA's FOI Staff (HFI-35), 5600 Fishers Lane, rm. 12A-16, 
Rockville, MD 20857.