Mentholatum Aims To Ice FDA Warning Letter Concerns
This article was originally published in The Tan Sheet
Executive Summary
The Mentholatum Co. is continuing to sell its Migraine Ice cooling headache pads during ongoing negotiations with FDA regarding the labeling claims for the OTC device. FDA cited unapproved headache and migraine relief claims in an April 18 warning letter to the firm.
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Migraine Ice
Mentholatum's "Cooling Headache Pads" reaching food, drug and mass outlets nationwide in May. The pads contain a "water-based gel with natural ingredients" and are shaped to fit the forehead, temples and back of the neck. Pads for the back of the neck and temple come four to a box, while forehead pads come five to a box; each retails for $9.99. Labeling claims the line provides "Instant soothing, cooling relief that lasts for hours" and is "Safe to use with medications." Consumers can receive a free brochure on migraine management tips and $1-off coupons for Migraine Ice by calling Mentholatum at 877-2-SOOTHE or visiting the Web site www.migraineice.com
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