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§349.12. Ophthalmic demulcents. — Inbound Citations

21 C.F.R. § 349.12

Cited by 2 regulations in release Current.

Citations to 21 C.F.R. § 349.12 as a whole

  • (b) Any two or three ophthalmic demulcent active ingredients identified in § 349.12 may be combined.
  • (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.”