[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR347.52]

[Page 279-280]
 
                        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 
 
                           Subpart C_Labeling
 
Sec.  347.52  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 ``Uses'' 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 of 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.  
347.12(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.  
347.12(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.  
347.12(c). ``Relieves minor skin irritations due to: [select one or more 
of the following: 'insect bites,' 'minor cuts,' or 'minor scrapes'].'' 
[If more than one condition is used, each is preceded by a bullet.]
    (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.  
347.12(a) or witch hazel identified in Sec.  347.12(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.  
347.12(a) used as a compress or wet dressing. ``Do not cover compress or 
wet dressing with plastic to prevent evaporation.''
    (4) For products containing aluminum acetate identified in Sec.  
347.12(a) when labeled for use as a soak, compress, or wet

[[Page 280]]

dressing. ``When using this product [bullet] in some skin conditions, 
soaking too long may overdry''.
    (d) Directions. The labeling of the product contains the following 
information under the heading ``Directions'':
    (1) For products containing aluminum acetate identified in Sec.  
347.12(a)--(i) For products used as a soak. ``For use as a soak: 
[bullet] soak affected area for 15 to 30 minutes as needed, or as 
directed by a doctor [bullet] repeat 3 times a day or as directed by a 
doctor [bullet] discard solution after each use''.
    (ii) For products used as a compress or wet dressing. ``For use as a 
compress or wet dressing: [bullet] soak a clean, soft cloth in the 
solution [bullet] apply cloth loosely to affected area for 15 to 30 
minutes [bullet] repeat as needed or as directed by a doctor [bullet] 
discard solution after each use''.
    (2) For products containing aluminum sulfate identified in Sec.  
347.12(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.  
347.12(c). ``Apply as often as needed''.
    (e) Products formulated and labeled as a styptic pencil and that 
meet the criteria established in Sec.  201.66(d)(10) of this chapter. 
The title, headings, subheadings, and information described in Sec.  
201.66(c) of this chapter shall be printed in accordance with the 
following specifications:
    (1) The labeling shall meet the requirements of Sec.  201.66(c) of 
this chapter except that the headings and information described in Sec.  
201.66(c)(3) and (c)(7) may be omitted, and the headings, subheadings, 
and information described in Sec.  201.66(c)(4) and (c)(5) may be 
presented as follows:
    (i) The heading and indication required by Sec.  201.66(c)(4) of 
this chapter may be limited to: ``Use [in bold type] stops bleeding of 
minor cuts from shaving''.
    (ii) The ``external use only'' warning in Sec.  347.52(c)(1) and in 
Sec.  201.66(c)(5)(i) of this chapter may be omitted. The second warning 
in Sec.  347.52(c)(1) may state: ``avoid contact with eyes''. The 
warning in Sec.  201.66(c)(5)(x) may be limited to the following: ``Keep 
out of reach of children.'' The subheadings in Sec.  201.66(c)(5)(iii) 
through (c)(5)(vii) may be omitted, provided the information after the 
heading ``Warning'' contains the warnings in this paragraph.
    (2) The labeling shall be printed in accordance with the 
requirements of Sec.  201.66(d) of this chapter except that any 
requirements related to Sec.  201.66(c)(3) and (c)(7), and the 
horizontal barlines and hairlines described in Sec.  201.66(d)(8), may 
be omitted.

[68 FR 33377, June 4, 2003, as amended at 68 FR 35293, June 13, 2003; 69 
FR 3005, Jan. 22, 2004]