§349.18. Ophthalmic vasoconstrictors. — Inbound Citations

(a) Any single ophthalmic astringent active ingredient identified in § 349.10 may be combined with any single ophthalmic vasoconstrictor active ingredient identified in § 349.18.

(c) 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:

(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) “Ask a doctor before use if you have [in bold type] narrow angle glaucoma.”

(3) “Overuse of this product may produce increased redness of the eye.”

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

(5) “When using this product [in bold type] pupils may become enlarged temporarily.”