[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR347.60]

[Page 280-281]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 347_SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN
USE--Table of Contents
 
                           Subpart C_Labeling
 
Sec. 347.60  Labeling of permitted combinations of active ingredients.

    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. 
For a combination drug product that does not have an established name, 
the labeling of the product states the statement of identity for each 
ingredient in the combination, as established in the statement of 
identity sections of the applicable OTC drug monographs.
    (b) Indications. The labeling of the product states, under the 
heading ``Uses,'' the indication(s) for each ingredient in the 
combination as established in the indications sections of the applicable 
OTC drug monographs, unless otherwise stated in this paragraph (b). 
Other truthful and nonmisleading statements, describing only the 
indications for use that have been established in the applicable OTC 
drug monographs or 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

[[Page 281]]

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. In addition to the required 
information identified in this paragraph (b), the labeling of the 
product may contain any of the ``other allowable statements'' that are 
identified in the applicable monographs, provided such statements are 
neither placed in direct conjunction with information required to appear 
in the labeling nor occupy labeling space with greater prominence or 
conspicuousness than the required information.
    (1) Combinations of skin protectant and external analgesic active 
ingredients in Sec. 347.20(b). In addition to any or all of the 
indications for skin protectant drug products in Sec. 347.50(b)(1), any 
or all of the allowable indications for external analgesic drug products 
may be used if the product is labeled for concurrent symptoms.
    (2) Combinations of skin protectant and first aid antiseptic active 
ingredients in Sec. 347.20(c). In addition to any or all of the 
indications for skin protectant drug products in Sec. 347.50(b)(1), the 
required indications for first aid antiseptic drug products should be 
used.
    (3) Combinations of skin protectant and sunscreen active ingredients 
in Sec. 347.20(d). In addition to any or all of the indications for 
skin protectant drug products in Sec. 347.50(b)(2)(i), the required 
indications for sunscreen drug products should be used and any or all of 
the additional indications for sunscreen drug products may be used.
    (c) Warnings. The labeling of the product states, under the heading 
``Warnings,'' the warning(s) for each ingredient in the combination, as 
established in the warnings section of the applicable OTC drug 
monographs unless otherwise stated in this paragraph (c).
    (1) For combinations containing a skin protectant and a sunscreen 
identified in Sec. Sec. 347.20(d) and 352.20(b). The warnings for 
sunscreen drug products in Sec. 352.60(c) of this chapter are used.
    (2) [Reserved]
    (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) For combinations containing a skin protectant and a sunscreen 
identified in Sec. Sec. 347.20(d) and 352.20(b). The directions for 
sunscreen drug products in Sec. 352.60(d) of this chapter are used.
    (2) [Reserved]