[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR347.50]

[Page 268]
 
                        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. 347.50  Labeling of astringent 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 
``astringent.''
    (b) Indications. The labeling of the product states, under the 
heading ``Indications'' any of the phrases listed in this paragraph (b), 
as appropriate. Other truthful and nonmisleading statements describing 
only the indications for use that have been established and listed in 
this paragraph (b) 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 products containing aluminum acetate identified in 
Sec. 347.10(a). ``For temporary relief of minor skin irritations due 
to'' (select one or more of the following: ``poison ivy,'' ``poison 
oak,'' ``poison sumac,'' ``insect bites,'' ``athlete's foot,'' or 
``rashes caused by soaps, detergents, cosmetics, or jewelry'').
    (2) For products containing aluminum sulfate identified in 
Sec. 347.10(b) for use as a styptic pencil. ``Stops bleeding caused by 
minor surface cuts and abrasions as may occur during shaving.''
    (3) For products containing witch hazel identified in 
Sec. 347.10(c). (i) ``For relief of minor skin irritations due to'' 
(select one or more of the following: ``insect bites,'' ``minor cuts,'' 
or ``minor scrapes'').
    (c) Warnings. The labeling of the product contains the following 
warnings under the heading ``Warnings'':
    (1) ``For external use only. Avoid contact with the eyes.''
    (2) For products containing aluminum acetate identified in 
Sec. 347.10(a) or witch hazel identified in Sec. 347.10(c). ``If 
condition worsens or symptoms persist for more than 7 days, discontinue 
use of the product and consult a'' (select one of the following: 
``physician'' or ``doctor'').
    (3) For products containing aluminum acetate identified in 
Sec. 347.10(a) used as a compress or wet dressing. ``Do not cover 
compress or wet dressing with plastic to prevent evaporation.''
    (d) Directions. The labeling of the product contains the following 
information under the heading ``Directions'':
    (1) For products containing aluminum acetate identified in 
Sec. 347.10(a)--(i) For products used as a soak. ``For use as a soak: 
Soak affected area in the solution for 15 to 30 minutes. Discard 
solution after each use. Repeat 3 times a day.''
    (ii) For products used as a compress or wet dressing. ``For use as a 
compress or wet dressing: saturate a clean, soft, white cloth (such as a 
diaper or torn sheet) in the solution, gently squeeze, and apply loosely 
to the affected area. Saturate the cloth in the solution every 15 to 30 
minutes and apply to the affected area. Discard solution after each use. 
Repeat as often as necessary.''
    (2) For products containing aluminum sulfate identified in 
Sec. 347.10(b) for use as a styptic pencil. ``Moisten tip of pencil with 
water and apply to the affected area. Dry pencil after use.''
    (3) For products containing witch hazel identified in 
Sec. 347.10(c). ``Apply to the affected area as often as necessary.''

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

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