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§349.16. Ophthalmic hypertonicity agent. — Inbound Citations

21 C.F.R. § 349.16

Cited by 1 regulation in release Current.

Citations to 21 C.F.R. § 349.16 as a whole

  • (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.”