Drug product
Dermatend Original, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.17 OZ (5g) container, Solace International, Inc., Reno, NV 89509, USA
D-1585-2014
Product summary
- Event
- Event 69135
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1606 containers
- Official record key
drug-enforcement:D-1585-2014
Official wording
Reason: 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.
Code information: All lots
Distribution pattern: Amazon US and Amazon UK
Derived failure modes
-
Unknown
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.