---
kind: "section"
citation: "21 C.F.R. § 349.12"
title: "21"
number: "349.12"
heading: "Ophthalmic demulcents."
url: "https://uscodex.org/cfr/21/349.12"
---

# §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) 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.

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

### Source

Source: 53 FR 7090, Mar. 4, 1988, unless otherwise noted.

### Amendments

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