[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR358.750]

[Page 299-300]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 358--MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
    Subpart H--Drug Products for the Control of Dandruff, Seborrheic 
                        Dermatitis, and Psoriasis
 
Sec. 358.750  Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis.

    (a) Statement of identity. The labeling of the product contains the 
established name of the drug, if any, and identifies the product with 
one or more of the following, as appropriate:
    (1) ``Dandruff (insert product form)'' or ``antidandruff (insert 
product form)''.
    (2) ``Seborrheic dermatitis (insert product form)''.
    (3) ``Psoriasis (insert product form)''.
    (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 terms listed in paragraph (b)(2) or 
(b)(3) 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 relief of'' or ``Controls'') ``the symptoms of'' (select 
one or more of the following, as appropriate: ``dandruff,'' ``seborrheic 
dermatitis,'' and/or ``psoriasis.'')
    (2) The following terms or phrases may be used in place of or in 
addition to the words ``For the relief of'' or ``Controls'' in the 
indications in paragraph (b)(1) of this section: ``fights,'' 
``reduces,'' ``helps eliminate,'' ``helps stop,'' ``controls recurrence 
of,'' ``fights recurrence of,'' ``helps prevent recurrence of,'' 
``reduces recurrence of,'' ``helps eliminate recurrence of,'' ``helps 
stop recurrence of.''
    (3) The following terms may be used in place of the words ``the 
symptoms of'' in the indications in paragraph (b)(1) of this section: 
(``skin'' and/or ``scalp,'' as appropriate) (select one or more of the 
following: ``itching,'' ``irritation,'' ``redness,'' ``flaking,'' 
``scaling,'') ``associated with.''
    (c) Warnings. The labeling of the product contains the following 
warnings under the heading ``Warnings'':
    (1) For products containing any ingredient identified in 
Sec. 358.710. (i) ``For external use only.''
    (ii) ``Avoid contact with the eyes. If contact occurs, rinse eyes 
thoroughly with water.''
    (iii) ``If condition worsens or does not improve after regular use 
of this product as directed, consult a doctor.''
    (2) For any product containing coal tar identified in 
Sec. 358.710(a), (b), or (c). (i) ``Use caution in exposing skin to 
sunlight after applying this product. It may increase your tendency to 
sunburn for up to 24 hours after application.''
    (ii) ``Do not use for prolonged periods without consulting a 
doctor.''
    (3) For products containing coal tar when formulated to be applied 
and left on the skin (e.g., creams, ointments, lotions). ``Do not use 
this product in or around the rectum or in the genital area or groin 
except on the advice of a doctor.''
    (4) For products containing coal tar identified in Sec. 358.710(c) 
for the control of psoriasis. ``Do not use this product with other forms 
of psoriasis therapy such as ultraviolet radiation or prescription drugs 
unless directed to do so by a doctor.''
    (5) For products containing any ingredient identified in 
Sec. 358.710(b) or (c) for the control of seborrheic dermatitis or 
psoriasis. ``If condition covers a large area of the body, consult your 
doctor before using this product.''
    (d) Directions. The labeling of the product contains the following 
information under the heading ``Directions.'' More detailed directions 
applicable to a particular product formulation may also be included.
    (1) For products containing active ingredients for the control of 
dandruff, seborrheic dermatitis, or psoriasis when formulated to be 
applied and then washed off after brief (a few minutes) exposure (e.g, 
shampoos, preshampoo rinses,

[[Page 300]]

postshampoo rinses). ``For best results use at least twice a week or as 
directed by a doctor.''
    (2) For products containing active ingredients for the control of 
dandruff, seborrheic dermatitis, or psoriasis when formulated so as to 
be applied and left on the skin or scalp (e.g., creams, ointments, 
lotions, hairgrooms). ``Apply to affected areas one to four times daily 
or as directed by a doctor.''
    (3) For products containing active ingredients for the control of 
seborrheic dermatitis or psoriasis of the skin when formulated as soaps. 
``Use on affected areas in place of your regular soap.''
    (e) The word ``physician'' may be substituted for the word 
``doctor'' in any of the labeling statements in this section.