FDA-Drug2014-09-24Class II

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

Solace International Inc
Hazard

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.

Sold states
Amazon US and Amazon UK
Affected count
1249 containers and kits
Manufactured in
80 Continental Dr Ste 101, N/A, Reno, NV, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1586-2014

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