---
kind: "section"
citation: "21 C.F.R. § 349.70"
title: "21"
number: "349.70"
heading: "Labeling of ophthalmic hypertonicity drug products."
url: "https://uscodex.org/cfr/21/349.70"
---

# §349.70. Labeling of ophthalmic hypertonicity drug products.

- (a) **Statement of identity.** The labeling of the product contains the established name of the drug, if any, and identifies the product as a “hypertonicity” (select one of the following: “eye” or “ophthalmic”) “(insert dosage form, e.g., drops).”
- (b) **Indications.** The labeling of the product states, under the heading “Indications,” the following phrase: “For the temporary relief of corneal edema.”
- (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 [§ 349.16](/cfr/21/349.16.md):
  - (1) “Do not use this product except under the advice and supervision of a doctor. If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists, consult a doctor.”
  - (2) “This product may cause temporary burning and irritation on being instilled into the eye.”
  - (3) “If solution changes color or becomes cloudy, do not use.”
- (d) **Directions.** The labeling of the product contains the following information under the heading “Directions”: Instill 1 or 2 drops in the affected eye(s) every 3 or 4 hours, or as directed by a doctor.

## 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.