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Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Nature Relief is Conducting a Voluntary Recall of Nature Relief Instant Wart and Mole Remover
FOR IMMEDIATE RELEASE - June 22, 2011 - Nature Relief is voluntarily recalling Nature Relief Instant Wart and Mole Remover. Consumers are advised to discontinue use and immediately dispose of any used or unused portions of the product. It is suggested that you discard of the product and contents inside a plastic bag and place it into the garbage for safe and quick disposal, in order to expedite the recall process and avoid further handling.
The recall is effective immediately and is being undertaken voluntarily in conjunction with the FDA because the product is potentially unsafe and contains an ingredient that may result in harmful burns to the skin that was previously unknown by the company.
The FDA has advised that the active ingredient, calcium oxide, can cause severe burns of the skin, particularly to areas of thin or sensitive skin, such as the face, area around the eyes, and genitalia. The FDA has received a report of an injury associated with the use of this product, including burns to the skin that required medical attention.
In addition, the FDA advises that consumers are recommended to have moles reviewed by licensed medical professionals and ensure they are not cancerous. Moles when left untreated can possibly lead to melanoma a form of cancer and self-treatment of diseases such as cancer can cause a delay in early diagnosis, which may help prevent life threatening complications.
This product is sold as a kit, which contains the following items: two small containers labeled "Repair Cream", one container of "Antiseptic Wash", a package of "Triple Antibiotic Ointment", toothpicks, and a "vanity kit" with cotton balls, swabs, and nail files.
This recall is being made in cooperation with the US Food and Drug Administration.
Consumers who purchased NatureRelief Instant Wart and Mole Remover should immediately discontinue their use and discard the remaining contents. Consumers with questions may contact Nature Relief customer care at 1-888-646-6399 or email the company at firstname.lastname@example.org.
Consumers who experience adverse events with this product should seek immediate help from their physician or healthcare provider.
Nature Relief is a 5-month-old small start up company that operated with 1 employee and only sold a very small quantity of the product through direct to consumer Internet marketing. No sales were conducting with distributors, wholesalers or retailers. Nature Relief did not turn a profit and revenue was only generated through the sales of the one product "Instant Wart Mole Remover".
All sales and operations of Nature Relief have now been temporally ceased.
Any adverse reactions experienced with the use of this product should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at Med Watch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the Med Watch website at www.fda.gov/medwatch.