[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: 21CFR333.160]

[Page 226-227]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 333_TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR 
OVER-THE-COUNTER HUMAN USE--Table of Contents
 
              Subpart B_First Aid Antibiotic Drug Products
 
Sec. 333.160  Labeling of permitted combinations of active ingredients.

    Statements 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 ``Indications,'' 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. Other truthful and nonmisleading statements, describing only 
the indications for use that have been established and listed in this 
paragraph (b), may also be used, as provided in Sec. 330.1(c)(2), 
subject to the provisions of section 502 of 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 permitted combinations identified in Sec. 333.120(a). The 
indications in Sec. 333.150 should be used.
    (2) For permitted combinations identified in Sec. 333.120(b). In 
addition to the required indication identified in Sec. 333.150, the 
labeling of the product may state, under the heading ``Indications,'' 
the following additional indication: ``First aid for the temporary 
relief of'' (select one of the following: ``pain,'' ``discomfort,'' 
``pain or discomfort'' or ``pain and itching'') ``in minor cuts, 
scrapes, and burns.''
    (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 sections of the applicable OTC drug 
monographs.
    (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. When the time intervals or age 
limitations for administrations of the individual ingredients differ, 
the directions

[[Page 227]]

for the combination product may not exceed any maximum dosage limits 
established for the individual ingredients in the applicable OTC drug 
monograph.