OTC vasoconstrictor eyedrop pupil dilation warning proposed by FDA.
This article was originally published in The Tan Sheet
Executive Summary
OTC OPHTHALMIC VASOCONSTRICTORS PUPIL DILATION WARNING PROPOSED BY FDA in a notice published in the Feb. 23 Federal Register. The proposed rule would amend the 1988 FDA final monograph for OTC eye allergy relief drug products to include the statement, "Pupils may become dilated (enlarged)." The vasoconstrictor ingredients covered under the proposed rule would include ephedrine, naphazoline, phenylephrine and tetrahydrozoline.
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A pupil dilation warning on both single- and combination-ingredient OTC vasoconstrictor eyedrops will be required by FDA despite previous objections from industry.
Vasoconstrictor Pupil Dilation Warning Established In Final Rule
A pupil dilation warning on both single- and combination-ingredient OTC vasoconstrictor eyedrops will be required by FDA despite previous objections from industry.