Ophthalmic drug products for over-the-counter human use; proposed amendment of final monograph--FDA. Proposed rule. Federal register. [Fed Regist] Journal article

Title	Ophthalmic drug products for over-the-counter human use; proposed amendment of final monograph--FDA. Proposed rule.
Source	Fed Regist 1998 Feb 23; 63(35):8888-90.
MeSH	Drug Approval Drugs, Non-Prescription Humans Mydriasis Ophthalmic Solutions Product Labeling Pupil United States United States Food and Drug Administration
Abstract	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.
Language	eng
Pub Type(s)	Journal Article
PubMed ID	10177740

Advertise on this site.