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Ophthalmic Drug Products for Over-The-Counter Human Use; Proposed Amendment of Final Monograph
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Zusammenfassung
The Food and Drug Administration (FDA) is proposing to amend the final monograph for over-the-counter (OTC) ophthalmic drug products. The amendment adds a new warning and revises an existing warning for ophthalmic vasoconstrictor drug products. These products contain the ingredients ephedrine hydrochloride, naphazoline hydrochloride, phenylephrine hydrochloride, or tetrahydrozoline hydrochloride; and they are used to relieve redness of the eye due to minor eye irritations. This proposal is part of the ongoing review of OTC drug products conducted by FDA.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →