Recalls & Warnings
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Posted June 13, 2022
“Natural” and OTC Mole, Skin Tag Removal Products Can Be Dangerous, Warns FDA
On June 9, 2022, the FDA warned consumers not to use “natural” or over-the-counter (OTC) products promoted to treat or remove moles, skin tags, and seborrheic keratoses because they can contain potentially dangerous concentrations of salicylic acid or other harmful ingredients.
There is currently no FDA approved prescription or OTC drug for treating moles, seborrheic keratoses, or skin tags. “Natural” and OTC products promoted to remove moles and skin tags are often sold as ointments, gels, sticks, and liquids. The high concentration of salicylic acid in these products can cause skin injury which can be permanent, infection requiring antibiotics, skin discoloration and scarring. Using these products can also make it more difficult for physicians to assess whether a mole or skin lesion may be cancerous and delay diagnosis and treatment for skin cancer (melanoma).
The agency advised that consumers should consult with a healthcare provider to evaluate, treat, and/or remove skin growths such as moles and other skin lesions.
It also emphasized that mole and skin tag removal products promoted as “all natural,” herbal, or homeopathic are not safe simply because they are labeled as “natural.” These products can also contain high concentrations of salicylic acid even if it is not listed as an ingredient on the label. Be aware that certain herbal ingredients, such as willow bark, naturally contain salicylic acid. It’s also possible that some people may have allergic reactions to salicylic acid or other ingredients found in such products.
The FDA also reminded health care professionals and consumers they may report adverse reactions or quality problems experienced with the use of these products through the FDA’s MedWatch Adverse Event Reporting.
For information about related products, see ConsumerLab’s answer to Can bloodroot or "black salve" treat skin cancer? Is it safe?
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