Bee-Shield Hand Sanitizer doesn’t work: FDA

Who buys a hand sanitizer named Bee-Shield; is it also an insect repellant?

The U.S. Food and Drug Administration said Friday that $230,000 worth of hand sanitizing gel made by Puerto Rico Beverage Inc. of Maunabo and distributed by Lord Pharmaceutical, LLC, doing business as Bee International Distributors was seized the day before.

The hand sanitizer is distributed only in Puerto Rico.

The product Bee-Shield Hand Sanitizer with Aloe Vera (10 fl. oz. or 1 gallon bottles) is an unapproved new drug and in violation of federal law

The gel was marketed as a product that could kill 99.99 percent of viruses, bacteria, and fungi. However, its safety and effectiveness have not been established. Additionally, the active ingredient, benzalkonium chloride, is not recognized as safe and effective for over-the-counter (OTC) antifungal use, making it noncompliant with FDA’s final monograph for OTC topical antifungal drug products.

The product also represents that it prevents the disease caused by the H1N1 influenza virus, that it is effective against viruses and provides extended antimicrobial efficacy. The FDA is unaware of any scientific evidence to support these claims.

On March 3, 2010, the FDA warned consumers not to use this product because it contained high levels of a bacterium, Burkholderia cepacia, that can cause serious infections in humans.
 

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About Douglas Powell

A former professor of food safety and the publisher of barfblog.com, Powell is passionate about food, has five daughters, and is an OK goaltender in pickup hockey. Download Doug’s CV here. Dr. Douglas Powell editor, barfblog.com retired professor, food safety 3/289 Annerley Rd Annerley, Queensland 4103 dpowell29@gmail.com 61478222221 I am based in Brisbane, Australia, 15 hours ahead of Eastern Standard Time