[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: 21CFR349.18]

[Page 271]
 
                        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. 349.18  Ophthalmic vasoconstrictors.

    The active ingredient of the product consists of one of the 
following, within the established concentration for each ingredient:
    (a) Ephedrine hydrochloride, 0.123 percent.
    (b) Naphazoline hydrochloride, 0.01 to 0.03 percent.
    (c) Phenylephrine hydrochloride, 0.08 to 0.2 percent.
    (d) Tetrahydrozoline hydrochloride, 0.01 to 0.05 percent.