§349.50. Labeling of ophthalmic drug products. — Inbound Citations

(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 § 349.10:

(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.”

(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 § 349.12:

(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.”

(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 § 349.14: “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.”

(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 § 349.16:

(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.”

(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.”

(c) In addition to the warnings in § 349.50, the labeling of the product contains the following warnings under the heading “Warnings” for all eyewash products:

(1) “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) “Obtain immediate medical treatment for all open wounds in or near the eyes.”

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