THURSDAY, Sept. 20 (HealthDay News) -- The U.S. Food and Drug Administration has warned Procter & Gamble against marketing its foaming hand sanitizer, Vicks Early Defense Foaming Hand Sanitizer, to schoolchildren because the company claims that it kills germs that cause colds.
If the product acts as indicated, it would make it an unapproved new drug, according to the FDA.
A proposed over-the-counter monograph for triclosan, the hand sanitizer's active ingredient, requires product labeling instructing users to rinse with water. The labeling for the hand sanitizer says it should be applied to hands and allowed to dry without wiping.
"FDA is concerned with the marketing of this over-the-counter drug for use by schoolchildren and others," Steven K. Galson, M.D., M.P.H., director of the FDA's Center for Drug Evaluation and Research, said in a statement. "Over-the-counter drugs are often widely used without supervision by a doctor or other health care professional, so it is essential that manufacturers obtain FDA approval or fully comply with over-the-counter monographs and agency policies."
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