[Code of Federal Regulations]
[Title 21, Volume 5, Parts 300 to 499]
[Revised as of April 1, 1997]
[CITE: 21CFR358]
[Page 287-289]
 
                        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

    Source:  56 FR 63568, Dec. 4, 1991, unless otherwise noted.

Sec. 358.701  Scope.

    (a) An over-the-counter dandruff, seborrheic dermatitis, or 
psoriasis drug product in a form suitable for topical application is 
generally recognized as safe and effective and is not misbranded if it 
meets each of the conditions in this subpart and each general condition 
established in Sec. 330.1 of this chapter.
    (b) References in this subpart to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21 unless otherwise noted.

Sec. 358.703  Definitions.

    As used in this subpart:

[[Page 288]]

    (a) Coal tar. The tar used for medicinal purposes that is obtained 
as a byproduct during the destructive distillation of bituminous coal at 
temperatures in the range of 900  deg.C to 1,100  deg.C. It may be 
further processed using either extraction with alcohol and suitable 
dispersing agents and maceration times or fractional distillation with 
or without the use of suitable organic solvents.
    (b) Dandruff. A condition involving an increased rate of shedding of 
dead epidermal cells of the scalp.
    (c) Psoriasis. A condition of the scalp or body characterized by 
irritation, itching, redness, and extreme excess shedding of dead 
epidermal cells.
    (d) Seborrheic dermatitis. A condition of the scalp or body 
characterized by irritation, itching, redness, and excess shedding of 
dead epidermal cells.
    (e) Selenium sulfide, micronized. Selenium sulfide that has been 
finely ground and that has a median particle size of approximately 5 
micrometers (<greek-m>m), with not more than 0.1 percent of the 
particles greater than 15 <greek-m>m and not more than 0.1 percent of 
the particles less than 0.5 <greek-m>m.

[56 FR 63568, Dec. 4, 1991, as amended at 59 FR 4001, Jan. 28, 1994]

Sec. 358.710  Active ingredients for the control of dandruff, seborrheic 
          dermatitis, or psoriasis.

    The active ingredient of the product consists of any of the 
following within the specified concentration established for each 
ingredient:
    (a) Active ingredients for the control of dandruff. (1) Coal tar, 
0.5 to 5 percent. When a coal tar solution, derivative, or fraction is 
used as the source of the coal tar, the labeling shall specify the 
identity and concentration of the coal tar source used and the 
concentration of the coal tar present in the final product.
    (2) Pyrithione zinc, 0.3 to 2 percent when formulated to be applied 
and then washed off after brief exposure.
    (3) Pyrithione zinc, 0.1 to 0.25 percent when formulated to be 
applied and left on the skin or scalp.
    (4) Salicylic acid, 1.8 to 3 percent.
    (5) Selenium sulfide, 1 percent.
    (6) Selenium sulfide, micronized, 0.6 percent.
    (7) Sulfur, 2 to 5 percent.
    (b) Active ingredients for the control of seborrheic dermatitis. (1) 
Coal tar, 0.5 to 5 percent. When a coal tar solution, derivative, or 
fraction is used as the source of the coal tar, the labeling shall 
specify the identity and concentration of the coal tar source used and 
the concentration of the coal tar present in the final product.
    (2) Pyrithione zinc, 0.95 to 2 percent when formulated to be applied 
and then washed off after brief exposure.
    (3) Pyrithione zinc, 0.1 to 0.25 percent when formulated to be 
applied and left on the skin or scalp.
    (4) Salicylic acid, 1.8 to 3 percent.
    (5) Selenium sulfide, 1 percent.
    (c) Active ingredients for the control of psoriasis. (1) Coal tar, 
0.5 to 5 percent. When a coal tar solution, derivative, or fraction is 
used as the source of the coal tar, the labeling shall specify the 
identity and concentration of the coal tar source used and the 
concentration of the coal tar present in the final product.
    (2) Salicylic acid, 1.8 to 3 percent.

[56 FR 63568, Dec. 4, 1991, as amended at 59 FR 4001, Jan. 28, 1994]

Sec. 358.720  Permitted combinations of active ingredients.

    Salicylic acid identified in Sec. 358.710(a) (4) may be combined 
with sulfur identified in Sec. 358.710(a)(6) provided each ingredient is 
present within the established concentration and the product is labeled 
for the control of dandruff.

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

[[Page 289]]

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, 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.

[end]