[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR349.30]

[Page 272]
 
                        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 B--Active Ingredients
 
Sec. 349.30  Permitted combinations of active ingredients.

    The following combinations are permitted provided each active 
ingredient is present within the established concentration, and the 
product is labeled in accordance with Sec. 349.79.
    (a) Any single ophthalmic astringent active ingredient identified in 
Sec. 349.10 may be combined with any single ophthalmic vasoconstrictor 
active ingredient identified in Sec. 349.18.
    (b) Any two or three ophthalmic demulcent active ingredients 
identified in Sec. 349.12 may be combined.
    (c) Any single ophthalmic demulcent active ingredient identified in 
Sec. 349.12 or any ophthalmic demulcent combination identified in 
paragraph (b) of this section may be combined with any single ophthalmic 
vasoconstrictor identified in Sec. 349.18.
    (d) Any single ophthalmic astringent active ingredient identified in 
Sec. 349.10 may be combined with any single ophthalmic vasoconstrictor 
active ingredient identified in Sec. 349.18 and any single ophthalmic 
demulcent identified in Sec. 349.12 or ophthalmic demulcent combination 
identified in paragraph (b) of this section.
    (e) Any two or more emollient active ingredients identified in 
Sec. 349.14 may be combined as necessary to give the product proper 
consistency for application to the eye.