Title 21

SECTION 350.60

350.60 Guidelines for effectiveness testing of antiperspirant drug products.

§ 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 Division of Freedom of Information (address is located on the agency's web site at http://www.fda.gov.

[68 FR 34291, June 9, 2003, as amended at 76 FR 31470, June 1, 2011; 79 FR 68115, Nov. 14, 2014]

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