[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: 21CFR350.50]

[Page 289-290]
 
                        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 C_Labeling
 
Sec. 350.50  Labeling of antiperspirant drug products.


    (a) Statement of identity. The labeling of the product contains the 
established name of the drug, if any, and identifies the product as an 
``antiperspirant.''
    (b) Indications. The labeling of the product states, under the 
heading ``Uses,'' the phrase listed in paragraph (b)(1) of this section 
and may contain any additional phrases listed in paragraphs (b)(2) 
through (b)(5) of this section, as appropriate. Other truthful and 
nonmisleading statements, describing only the uses that have been 
established and listed in paragraphs (b)(1) through (b)(5) of this 
section, may also be used, as provided in Sec. 330.1(c)(2) of this 
chapter, subject to the provisions of section 502 of the Federal Food, 
Drug, and Cosmetic Act (the act) relating to misbranding and the 
prohibition in section 301(d) of the act against the introduction or 
delivery for introduction into interstate commerce of unapproved new 
drugs in violation of section 505(a) of the act.
    (1) For any product, the labeling states [select one of the 
following: ``decreases,'' ``lessens,'' or ``reduces''] ``underarm'' 
[select one of the following: ``dampness,'' ``perspiration,'' ``sweat,'' 
``sweating,'' or ``wetness''].
    (2) The labeling may state ``also [select one of the following: 
`decreases,' `lessens,' or `reduces'] underarm [select one of the 
following: `dampness,' `perspiration,' `sweat,' `sweating,' or 
`wetness'] due to stress''.
    (3) For products that demonstrate standard effectiveness (20 percent 
sweat reduction) over a 24-hour period, the labeling may state [select 
one of the following: ``all day protection,'' ``lasts all day,'' ``lasts 
24 hours,'' or ``24 hour protection''].
    (4) For products that demonstrate extra effectiveness (30 percent 
sweat reduction), the labeling may state ``extra effective''.
    (5) Products that demonstrate extra effectiveness (30 percent sweat 
reduction) sustained over a 24-hour period may state the claims in 
paragraphs (b)(3) and (b)(4) of this section either individually or 
combined, e.g., ``24 hour extra effective protection'', ``all day extra 
effective protection,'' ``extra effective protection lasts 24 hours,'' 
or ``extra effective protection lasts all day''.
    (c) Warnings. The labeling of the product contains the following 
statements under the heading ``Warnings'':
    (1) ``Do not use on broken skin''.
    (2) ``Stop use if rash or irritation occurs''.
    (3) ``Ask a doctor before use if you have kidney disease''.
    (4) For products in an aerosolized dosage form. (i) ``When using 
this product

[[Page 290]]

[bullet]\1\ keep away from face and mouth to avoid breathing it''.
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    \1\ See Sec. 201.66(b)(4) of this chapter for definition of bullet.
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    (ii) The warning required by Sec. 369.21 of this chapter for drugs 
in dispensers pressurized by gaseous propellants.
    (d) Directions. The labeling of the product contains the following 
statement under the heading ``Directions'': ``apply to underarms only''.

    Effective Date Note: At 69 FR 61149, Oct. 15, 2004, the limitation 
of the enhanced duration claim to 24 hours (21 CFR 350.50 (b)(3) and (b) 
(5)) was stayed until further notice.