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Contact:
The Mentholatum Company, Inc.
1-877-636-2677
FOR IMMEDIATE RELEASE -- Orchard Park, NY -- July 31, 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].
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