Ophthalmic drug products for over-the-counter human use; proposed amendment of final monograph--FDA. Proposed rule.
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.
D000075202:Contraindications; D017277:Drug Approval; D006801:Humans; D015878:Mydriasis / Q000139:chemically induced*; D004366:Nonprescription Drugs / Q000592:standards*; D009883:Ophthalmic Solutions / Q000009:adverse effects* / Q000592:standards*; D011356:Product Labeling / Q000331:legislation & jurisprudence* / Q000592:standards; D011680:Pupil / Q000187:drug effects*; D014481:United States; D014486:United States Food and Drug Administration