GroundRules
21 CFR 349.12: Ophthalmic demulcents.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER D—DRUGS FOR HUMAN USE
- PART 349—OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
- Subpart B—Active Ingredients
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) 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.
Collected 2026-08-27T02:24:47Z. Source file · JSON