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Recall: Cough & Cold Vapor Pads

From:Internet   Author:Admin   Time:2007-04-19   Font: [big center small]  

Aug. 2, 2006 -- The Mentholatum Company is recalling its WellPatch Cough & Cold Soothing Vapor Pads.

The reason for the recall: Kids could get sick -- and even have seizures -- if they remove a pad and chew on it.

People should stop using the product immediately and throw it away or return it to the place of purchase for a full refund, says a Mentholatum news release posted on the FDA's web site.

The recall is a "precautionary measure," says Mentholatum, which hadn't gotten any reports of serious adverse events related to the product as of July 31.

The vapor pads contain camphor, eucalyptus oil, and menthol. They're supposed to go on the throat or chest, so that the vapors can reach the nose and mouth.

The pads are labeled for use by children as young as 2 years old. Kids might be able to remove the patches and put them in their mouth, but the pads aren't intended for oral consumption.

Possible side effects from chewing on or ingesting products containing camphor or eucalyptus oils can vary from minor symptoms -- such as headache, nausea, vomiting, and burning sensation in the mouth -- to more severe reactions, such as seizures.

For More Information

The recall doesn't affect any other Mentholatum products. For more information, contact the company's customer service department at (877) 636-2677 or visit www.wellpatch.com.

Any adverse reactions to the vapor pads should also be reported to the FDA's MedWatch Adverse Event reporting program, which can be reached by phone at (800) FDA-1088 (800-332-1088) and online at www.fda.gov/MedWatch/report.htm.

Or, download the FDA's Form 3500 from www.fda.gov/MedWatch/getforms.htm, and send it to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or fax it to (800) FDA-0178 (800-332-0178).

In June, Novartis Consumer Health recalled all of its Triaminic Vapor Patches for the same reason.

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