[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR349.12]

[Page 283-284]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
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.

[[Page 284]]

    (2) Hydroxyethyl cellulose, 0.2 to 2.5 percent.
    (3) Hypromellose, 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.

[53 FR 7090, Mar. 4, 1988, as amended at 68 FR 32982, June 3, 2003]