---
kind: "section"
citation: "21 C.F.R. § 349.65"
title: "21"
number: "349.65"
heading: "Labeling of ophthalmic emollient drug products."
url: "https://uscodex.org/cfr/21/349.65"
---

# §349.65. Labeling of ophthalmic emollient drug products.

- (a) **Statement of identity.** The labeling of the product contains the established name of the drug(s), if any, and identifies the product as a “lubricant” or “emollient (lubricant)” (select one of the following: “eye” or “ophthalmic”) “(insert dosage form, e.g., ointment).”
- (b) **Indications.** The labeling of the product states, under the heading “Indications,” one or more of the following phrases:
  - (1) “For the temporary relief of burning and irritation due to dryness of the eye.”
  - (2) “For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.”
  - (3) “For use as a protectant against further irritation or to relieve dryness of the eye.”
  - (4) “For use as a lubricant to prevent further irritation or to relieve dryness of the eye.”
- (c) **Warnings.** In addition to the warnings in [§ 349.50](/cfr/21/349.50.md), the labeling of the product contains the following warnings under the heading “Warnings” for products containing any ingredient identified in [§ 349.14](/cfr/21/349.14.md): “If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.”
- (d) **Directions.** The labeling of the product contains the following information under the heading “Directions”: Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

## 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.