[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: 21CFR358.760]

[Page 318-319]
 
                        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--
 
    Subpart H_Drug Products for the Control of Dandruff, Seborrheic 
                        Dermatitis, and Psoriasis
 
Sec.  358.760  Labeling of permitted combinations of active ingredients for 

the control of dandruff.

    The statement of identity, indications, warnings, and directions for 
use, respectively, applicable to each ingredient in the product may be 
combined to eliminate duplicative words or phrases so that the resulting 
information is clear and understandable.
    (a) Statement of identity. For a combination drug product that has 
an established name, the labeling of the product states the established 
name of the combination drug product, followed by the statement of 
identity for each ingredient in the combination, as established in the 
statement of identity sections of the applicable OTC drug monographs.
    (1) Combinations of control of dandruff and external analgesic 
active ingredients in Sec.  358.720(b). The label states ``dandruff/
anti-itch shampoo'' or ``antidandruff/anti-itch shampoo''.
    (2) [Reserved]
    (b) Indications. The labeling of the product states, under the 
heading ``Uses,'' one or more of the phrases listed in this paragraph 
(b), as appropriate. Other truthful and nonmisleading statements, 
describing only the uses 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) Combinations of control of dandruff and external analgesic 
active ingredients in Sec.  358.720(b). The labeling states ``[bullet] 
[select one of the following: `for relief of' or `controls'] the 
symptoms of dandruff [bullet] [select one of the following: `additional' 
or `extra'] relief of itching due to dandruff''.
    (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 indication in paragraph (b)(1) of this section: 
``scalp'' (select one or

[[Page 319]]

more of the following: ``itching,'' ``irritation,'' ``redness,'' 
``flaking,'' ``scaling'') ``associated with''.
    (c) Warnings. The labeling of the product states, under the heading 
``Warnings,'' the warning(s) listed in Sec.  358.750(c)(1) and (c)(2).
    (d) Directions. The labeling of the product states, under the 
heading ``Directions,'' directions that conform to the directions 
established for each ingredient in the directions sections of the 
applicable OTC drug monographs, unless otherwise stated in this 
paragraph (d). When the time intervals or age limitations for 
administration of the individual ingredients differ, the directions for 
the combination product may not contain any dosage that exceeds those 
established for any individual ingredient in the applicable OTC drug 
monograph(s), and may not provide for use by any age group lower than 
the highest minimum age limit established for any individual ingredient.
    (1) Combinations of control of dandruff and external analgesic 
active ingredients in Sec.  358.720(b). The labeling states ``[bullet] 
wet hair [bullet] apply shampoo and work into a lather [bullet] rinse 
thoroughly [bullet] for best results, use at least twice a week or as 
directed by a doctor''.
    (2) [Reserved]

[72 FR 9852, Mar. 6, 2007]

    Effective Date Note: At 72 FR 9852, Mar. 6, 2007, Sec.  358.760 was 
added, effective April 5, 2007.