[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: 21CFR346.52]

[Page 274]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 346_ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of 
 
                           Subpart C_Labeling
 
Sec.  346.52  Labeling of permitted combinations of anorectal active 

ingredients.

    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 established in Sec.  346.50(a). For a combination drug product 
that does not have an established name, the labeling of the product 
states the statement of identity established in Sec.  346.50(a).
    (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 this subpart.
    (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 this subpart.
    (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 this 
subpart. When the time intervals or age limitations for administration 
of the individual ingredients differ, the directions for the combination 
product may not exceed any maximum dosage limits established for the 
individual ingredients in the applicable OTC drug monograph.