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§ 349.55 - Labeling of ophthalmic astringent drug products.

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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).”

Indications. The labeling of the product states, under the heading “Indications,” the following phrase: “For the temporary relief of discomfort from minor eye irritations.”

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:

“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.”

“If solution changes color or becomes cloudy, do not use.”

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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§ 349.50 - Labeling of ophthalmic drug products.
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§ 349.60 - Labeling of ophthalmic demulcent drug products.