---
kind: "section"
citation: "21 C.F.R. § 349.14"
title: "21"
number: "349.14"
heading: "Ophthalmic emollients."
url: "https://uscodex.org/cfr/21/349.14"
---

# §349.14. Ophthalmic emollients.


The active ingredients of the product consist of any of the following:

- (a) **Lanolin preparations—**
  - (1) Anhydrous lanolin, 1 to 10 percent in combination with one or more oleaginous emollient agents included in the monograph.
  - (2) Lanolin, 1 to 10 percent in combination with one or more oleaginous emollient agents included in the monograph.
- (b) **Oleaginous ingredients—**
  - (1) Light mineral oil, up to 50 percent in combination with one or more other emollient agents included in the monograph.
  - (2) Mineral oil, up to 50 percent in combination with one or more other emollient agents included in the monograph.
  - (3) Paraffin, up to 5 percent in combination with one or more other emollient agents included in the monograph.
  - (4) **Petrolatum, up to 100 percent.**
  - (5) **White ointment, up to 100 percent.**
  - (6) **White petrolatum, up to 100 percent.**
  - (7) White wax, up to 5 percent in combination with one or more other emollient agents included in the monograph.
  - (8) Yellow wax, up to 5 percent in combination with one or more other emollient agents included in the monograph.

## Notes

### Authority

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

### Source

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