![]() 11 The FDA allows inclusion of SA in topical OTC drug products marketed pursuant to OTC Drug Monographs at concentrations ranging from 0.5%–40%, depending on the indications, which include acne (0.5%–2%), psoriasis (1.8%–3%), and hyperkeratotic conditions like corns, calluses, and warts (5%–40%). SA is a keratolytic at concentrations between 3%–6%, becoming more destructive at higher concentrations. ![]() ![]() These cases prompted our further review of this issue. They applied the product to lesions on the face, neck, torso, and buttocks as directed and sustained burns with resulting scars. Ingredients included concentrated SA 25%. The FDA has received cases from consumers who reported purchasing mole and skin tag remover products from. canadensis, including cosmetic disfigurement, and death due to progression of inadequately treated malignancy. 7, 8 There are also case reports describing harm from S. 6 Two additional published case reports described scarring following the use of an unapproved mole and skin tag remover containing cashew and fig, which may cause skin irritation, and greater celandine, a plant containing the escharotic alkaloid sanguinarine, also found in Sanguinaria canadensis. 2 – 5 Awareness of these products will allow dermatologists to counsel patients to avoid them and seek appropriate interventions instead.Ī recent publication described skin injury related to a salicylic acid (SA)-containing mole and skin tag remover product. The FDA has warned against using over the counter (OTC) products marketed for self-removal of moles or skin tags and has also issued warning letters to firms who sold such products. 1 There are no FDA-approved drugs indicated to treat moles or skin tags. ![]() The American Academy of Dermatology (AAD) advises the public to “never try to remove a mole at home” due to risks of scarring, infection, and the possibility of malignancy in the mole of concern. ![]()
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