Active Ingredient
Salicylic acid 17%
Pureskin Wart Remover Solution
FDA Label NDC 87217-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Benlong Hall Llc for the product Pureskin Wart Remover (NDC 87217-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, do not use, stop use, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Wart remover, Corn & callus remover
Uses
■ for the removal of common warts. The common wart is easily recognized by the rough “cauliflower-like” appearance of the surface. ■ for the removal of plantar warts on the bottom of the foot. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern. ■ for the removal of corns and calluses
Warnings
For external use only. Flammable. Keep away from fire or flame.
When Using This Product
■ if product gets into the eye, flush with water for 15 minutes ■ avoid inhaling vapors
Do Not Use
■ this product on irritated skin, on any area that is infected or reddened, if you are a diabetic, or if you have poor ■ on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes
Stop Use
Stop use and ask a doctor if ■ discomfort persists
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
1. wash affected area. (May soak wart/corn in warm water for 5 minutes.) Dry area thoroughly. 2. apply a small amount at a time with brush to sufficiently cover each wart/corn. Let dry. 3. warts: repeat once or twice daily as needed (until wart is removed) for up to 12 weeks 4. corns/calluses: repeat once or twice daily as needed for up to 14 days (until corn/callus is removed) 5. children under 12 years of age: ask a doctor
Other Information
cap bottle tightly and store at room temperature away from heat
Inactive Ingredients
Alcohol, Pyroxylin, Sophora flavescens, Prunus Mume (sieb.), Cnidium Monnieri (L.) Cuss, Crocus Sativus L, Gleditsla sinensis Lam., cortex dictamni, Borneol, Kochia scoparia (L.) Schrad
Package
Package
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