Product: Dermatend Ultra, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.34 OZ (10g) container, Solace International, Inc., Reno, NV 89509, USA
Reason for recall: Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling.
Recall initiated: 20140828
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated