The Mentholatum Company Issues a Nationwide Voluntary Recall of WellPatch Cough & Cold Soothing Vapor Pads in the U.S.Aug 1, 2006 The Mentholatum Company announced today it is conducting a nationwide voluntary recall of WellPatch Cough & Cold Soothing Vapor Pads due to potential serious adverse health effects that could result if the product is ingested by a child removing the patch and chewing on it.
Consumers who have WellPatch Cough & Cold Soothing Vapor Pads should stop using them immediately. The Mentholatum Company is taking this precautionary action to ensure the safety of the consumers who use this product. To date, there have been no serious adverse events reported.
The Mentholatum Company is initiating the recall due to the possibility of adverse events associated with use of the product. WellPatch® Cough & Cold Soothing Vapor Pads contain camphor, eucalyptus oil, and menthol. Possible adverse events associated with chewing or ingesting products containing camphor or eucalyptus oils can vary from minor symptoms, such as burning sensation in the mouth, headache, nausea and vomiting, to more severe reactions, such as seizures.
The recall is being conducted with the knowledge of the FDA. WellPatch Cough & Cold Soothing Vapor Pads are labeled for use by children two (2) years of age and older. The directions on the label indicate the patch is to be applied to the throat or chest to allow the vapors to reach the nose and mouth. Once applied, the patch would be within close reach for a child to remove and place in his/her mouth. The Vapor Pad is a topical cough product applied externally and not intended for oral consumption.
The product is sold nationwide over-the-counter at pharmacies and retail stores. This recall affects only the Cough & Cold Soothing Vapor Pads. Consumers should immediately discontinue use of this product and return it to their point of purchase for a full refund or discard it. Consumers requiring more information about this recall can contact The Mentholatum Company Customer Service Department at 1-877-636-2677 or visit www.wellpatch.com.
Any adverse reactions experienced with the use of this product should also be reported to the FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].