[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR349.79]

[Page 274]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 349--OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
                           Subpart C--Labeling
 
Sec. 349.79  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 this part. 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 
this part.
    (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 part.
    (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 part.
    (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 part. 
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.