Statement of identity. The labeling of the product contains the established name of the drug(s), if any, and identifies the product as a “redness reliever” or “vasoconstrictor (redness reliever)” (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: “Relieves redness of the eye due to 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 § 349.18:
“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.”
“Ask a doctor before use if you have [in bold type] narrow angle glaucoma.”
“Overuse of this product may produce increased redness of the eye.”
“If solution changes color or becomes cloudy, do not use.”
“When using this product [in bold type] pupils may become enlarged temporarily.”
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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