21 CFR § 349.70 - Labeling of ophthalmic hypertonicity drug products.

---
identifier: "/us/cfr/t21/s349.70"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 349.70 - Labeling of ophthalmic hypertonicity drug products."
title_number: 21
title_name: "Food and Drugs"
section_number: "349.70"
section_name: "Labeling of ophthalmic hypertonicity drug products."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "349"
part_name: "OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 353, 355, 360, 371."
regulatory_source: "53 FR 7090, Mar. 4, 1988, unless otherwise noted."
cfr_part: "349"
---


# 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, the labeling of the product contains the following warnings under the heading “Warnings” for products containing any ingredient identified in § 349.16:

(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.