[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: 21CFR333.350]

[Page 229-230]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 333_TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--
 
                  Subpart D_Topical Acne Drug Products
 
Sec.  333.350  Labeling of acne 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 
``acne medication,'' ``acne treatment,'' ``acne medication'' (insert 
dosage form, e.g., ``cream,'' ``gel,'' ``lotion,'' or ``ointment''), or 
``acne treatment'' (insert dosage form, e.g., ``cream,'' ``gel,'' 
``lotion,'' or ``ointment'').
    (b) Indications. The labeling of the product states, under the 
heading ``Indications,'' the phrase listed in paragraph (b)(1) of this 
section and may contain any of the additional phrases listed in 
paragraph (b)(2) of this section. Other truthful and nonmisleading 
statements, describing only the indications for use that have been 
established and listed in paragraph (b) 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 the'' (select one of the following: ``management'' or 
``treatment'') ``of acne.''
    (2) In addition to the information identified in paragraph (b)(1) of 
this section, the labeling of the product may contain any one or more of 
the following statements:
    (i) (Select one of the following: ``Clears,'' ``Clears up,'' 
``Clears up most,'' ``Dries,'' ``Dries up,'' ``Dries and clears,'' 
``Helps clear,'' ``Helps clear up,'' ``Reduces the number of,'' or 
``Reduces the severity of'') (select one or more of the following: 
``acne blemishes,'' ``acne pimples,'' ``blackheads,'' or ``whiteheads'') 
which may be followed by ``and allows skin to heal.''
    (ii) ``Penetrates pores to'' (select one of the following: 
``eliminate most,'' ``control,'' ``clear most,'' or ``reduce the number 
of'') (select one or more of the following: ``acne blemishes,'' ``acne 
pimples,'' ``blackheads,'' or ``whiteheads'').
    (iii) ``Helps keep skin clear of new'' (select one or more of the 
following: ``acne blemishes,'' ``acne pimples,'' ``blackheads,'' or 
``whiteheads'').
    (iv) ``Helps prevent new'' (select one or more of the following: 
``acne blemishes,'' ``acne pimples,'' ``blackheads,'' or ``whiteheads'') 
which may be followed by ``from forming.''
    (v) ``Helps prevent the development of new'' (select one or more of 
the following: ``acne blemishes,'' ``acne pimples,'' ``blackheads,'' or 
``whiteheads'').
    (c) Warnings. The labeling of the product contains the following 
warnings under the heading ``Warnings'':
    (1) For products containing any ingredient identified in Sec.  
333.310. (i) ``For external use only.''
    (ii) ``Using other topical acne medications at the same time or 
immediately following use of this product may increase dryness or 
irritation of the skin. If this occurs, only one medication should be 
used unless directed by a doctor.''
    (2) For products containing sulfur identified in Sec. Sec.  333.310 
(d) and (e). ``Do not get into eyes. If excessive skin irritation 
develops or increases, discontinue use and consult a doctor.''
    (3) For products containing any combination identified in Sec.  
333.320. ``Apply to affected areas only. Do not use on broken skin or 
apply to large areas of the body.''
    (d) Directions. The labeling of the product contains the following 
information under the heading ``Directions'':
    (1) ``Cleanse the skin thoroughly before applying medication. Cover 
the entire affected area with a thin layer one to three times daily. 
Because excessive drying of the skin may occur, start

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with one application daily, then gradually increase to two or three 
times daily if needed or as directed by a doctor. If bothersome dryness 
or peeling occurs, reduce application to once a day or every other 
day.''
    (2) The directions described in paragraph (d)(1) of this section are 
intended for products that are applied and left on the skin. Other 
products, such as soaps or masks, may be applied and removed and should 
have appropriate directions.
    (3) Optional directions. In addition to the required directions in 
paragraphs (d)(1) and (d)(2) of this section, the product may contain 
the following optional labeling: ``Sensitivity Test for a New User. 
Apply product sparingly to one or two small affected areas during the 
first 3 days. If no discomfort occurs, follow the directions stated: 
(select one of the following: `elsewhere on this label,' `above,' or 
`below.')''
    (e) The word ``physician'' may be substituted for the word 
``doctor'' in any of the labeling statements in this section.