Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 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.

Where this section sits in the code

Title 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D—DRUGS FOR HUMAN USE
PART 349—OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart C—Labeling

(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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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