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."
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands
People In Brief
Perrigo promotes in pricing, planning