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OTC OXYMETAZOLINE, XYLOMETAZOLINE PEDIATRIC USE WITH CALIBRATED DROPPER

This article was originally published in The Tan Sheet

Executive Summary

OTC OXYMETAZOLINE, XYLOMETAZOLINE PEDIATRIC USE WITH CALIBRATED DROPPER or metered-dose spray is acceptable, FDA concluded in a final monograph on OTC nasal decongestants published in the Aug, 23 Federal Register. The agency explained that due to the "risk of overdose or misuse" of oxymetazoline and xylometazoline for children two to under six years of age, it is requiring that "pediatric products be marketed in a container with a controlled, metered-dose children's safety dropper that is calibrated to deliver no more than a maximum allowable dose."

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