[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: 21CFR349.12]

[Page 270]
 
                        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. 349.12  Ophthalmic demulcents.

    The active ingredients of the product consist of any of the 
following, within the established concentrations for each ingredient:
    (a) Cellulose derivatives:
    (1) Carboxymethylcellulose sodium, 0.2 to 2.5 percent.
    (2) Hydroxyethyl cellulose, 0.2 to 2.5 percent.
    (3) Hydroxypropyl methylcellulose, 0.2 to 2.5 percent.
    (4) Methylcellulose, 0.2 to 2.5 percent.
    (b) Dextran 70, 0.1 percent when used with another polymeric 
demulcent agent in this section.
    (c) Gelatin, 0.01 percent.
    (d) Polyols, liquid:
    (1) Glycerin, 0.2 to 1 percent.
    (2) Polyethylene glycol 300, 0.2 to 1 percent.
    (3) Polyethylene glycol 400, 0.2 to 1 percent.
    (4) Polysorbate 80, 0.2 to 1 percent.
    (5) Propylene glycol, 0.2 to 1 percent.
    (e) Polyvinyl alcohol, 0.1 to 4 percent.
    (f) Povidone, 0.1 to 2 percent.