Ophthalmic Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph

The Food and Drug Administration (FDA) is amending the monograph for over-the-counter (OTC) ophthalmic drug products (the regulation that establishes conditions under which these drug products are generally recognized as safe and effective and not misbranded). 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 are used to relieve redness of the eye due to minor eye irritations. This final rule is part of the ongoing review of OTC drug products conducted by FDA.