CFR

349.55—Labeling of ophthalmic astringent 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 an “astringent” (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 discomfort from minor eye irritations.”

(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 § 349.10 :

(1) “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.”

(2) “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 to 2 drops in the affected eye(s) up to four times daily.

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