§349.16. Ophthalmic hypertonicity agent. — Inbound Citations
21 C.F.R. § 349.16
Statutory Authority
Cited by 1 regulation in release Current.
Citations to 21 C.F.R. § 349.16 as a whole
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(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.”