Staphaseptic First Aid Antiseptic/Pain Relieving Gel

FDA Warns Companies About MRSA Claims

The agency sent warning letters to four companies selling OTC products bearing claims that they prevent methicillin-resistant Staphylococcus aureus infections.

The U.S. Food and Drug Administration warned four companies with letters sent April 20 that they must stop claiming that over-the-counter hand sanitizers and antiseptic gels will prevent MRSA infections. The statements are unproven, FDA said, and the letters mean the companies have 15 days to correct the claims or have the products seized.

MRSA is methicillin-resistant Staphylococcus aureus, a potential dangerous infection. One company claims that its hand sanitizing lotion prevents infection from E. coli and the H1N1 flu virus, while another claims its "patented formulation of essential plant oils" kills Salmonella. These claims are unproven and illegal, according to the agency.

"FDA has not approved any products claiming to prevent infection from MRSA, E. coli, Salmonella, or H1N1 flu, which a consumer can just walk into a store and buy," said Deborah Autor, compliance director at FDA's Center for Drug Evaluation and Research. "These products give consumers a false sense of protection."

"Staphylococcus aureus itself is a very aggressive organism," says Edward Cox, M.D., MPH, director of FDA's Office of Antimicrobial Products. "It's often associated with patients in hospitals who have weakened immune systems, but the bacterium can also cause significant skin infections and abscesses in a normal, healthy person. And it can get into the bloodstream and, less frequently, may involve the heart valve, which is very difficult to treat. With MRSA, a number of the antibiotic drugs we typically used often don't work, so we lose treatment options we used to rely upon."

Examples of unproven claims found on product labels are:

  • kills over 99.9% of MRSA
  • helps prevent skin infections caused by MRSA and other germs
  • is effective against a broad spectrum of pathogens, including MRSA

The letters concerned:

  • Staphaseptic First Aid Antiseptic/Pain Relieving Gel, by Tec Laboratories
  • Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant, by JD Nelson and Associates
  • Dr. Tichenor’s Antiseptic Gel, by Dr. G.H. Tichenor Antiseptic Co.
  • Clean Well All-Natural Hand Sanitizer, Clean Well All-Natural Hand Sanitizing Wipes, and Clean Well All-Natural Antibacterial Foaming Hand Soap, by Oh So Clean Inc., also known as CleanWell Company

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