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U.S. Department of Health and Human Services

Drugs

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FDA Clears Skin Lotion for Military to Protect Against Chemical Burns

FOR IMMEDIATE RELEASE
P03-24
March 28, 2003
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

The Food and Drug Administration (FDA) has cleared for use by the U.S. military a liquid decontamination lotion intended to remove or neutralize chemical warfare agents and T-2 fungal toxin from the skin.

The lotion, called Reactive Skin Decontamination Lotion (RSDL), must be applied to exposed skin as soon as possible after exposure to a chemical agent.

The lotion is impregnated in a sponge pad packaged as a single unit in a heat-sealed foil pouch. When exposed to chemical warfare agents, the user wipes the exposed skin with the lotion. The lotion removes the agents or the T-2 toxin and also reacts with the chemical agents, rapidly neutralizing them so they are non-toxic.

"If used in time, this lotion can help prevent the serious burns and deaths that results from exposure to chemical warfare agents," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "FDA worked with the U.S. Army to expedite review of this product to make it available to our men and women in uniform as quickly as possible."

FDA cleared the lotion for use based on studies conducted by the U.S. Department of the Army that showed it is safe and effective. The Army tested the product's safety by conducting skin irritation, sensitization and photo irritation studies in more than 300 people. It tested its effectiveness by using it to treat animals that had been exposed to chemical agents. The Canadian military and the U.S. military worked together to develop the scientific data on which FDA based clearance of the product.

RSDL is manufactured by O'Dell Engineering Ltd/E-Z-EM Canada Inc., Canada.