Active Ingredient
Salicylic Acid 17%
Gemachlich Zuhause Wart Remover Liquid
FDA Label NDC 76986-015
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Quadrant Ecological Technology Co., Ltd. for the product Gemachlich Zuhause Wart Remover (NDC 76986-015). 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, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Wart remover
Use
· for the removal of common and plantar warts
· the common wart is easily recognized by the rough "cauliflower-like"appearance on the surface.
· the plantar wart is recognized by its location only on the bottom of the foot, its tenderness and interruption of the footprint pattern.
Warnings
· For external use only.
· Flammable: Keep away from fire or flame.
· Ask a doctor before use if pregnant or nursing.
· Do not use if allergic to any ingredients in this product.
Do Not Use
·if there is any burning sensation, redness or swelling at the site of application.
·on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes.
·if you have diabetes or poor blood circulation.
When Using
avoid contact with eyes, nose and mouth. If contact occurs, rinse thoroughly with water.
Stop Use
Stop Using and ask a doctor if irritation or redness develops and lasts.
Ask Doctor
Stop Using and ask a doctor if irritation or redness develops and lasts.
Keep Out Of Reach Of Children
In case of accidental ingestion, get medical help or contact a poison control center immediately.
Directions
Wash the affected area.May soak wart in warm water for 5 minutes.Dry area thoroughly.Use the brush to apply a sufficient amount to cover each wart. Let it dry.
Repeat this procedure once or twice daily as needed (until wart is removed) for up to12 weeks.
Other Information
·Shielded from light, sealed, stored at room temperature.
·Skin discoloration may occur during or after use .
Inactive Ingredients
Alcohol, Water, Urea, Propylene Glycol, Triethanolamine, Dimethyl Isosorbide, Menthol, Sodium Hydroxide, Podophyllotoxin, Butylene Glycol, Benzoic Acid, Polyquaternium-10, Borneol, Disodium EDTA, Avena Sativa (Oat) Kernel Extract, Rosa Rugosa Flower Extract, Centella Asiatica Extract, Lactobacillus Ferment, Potassium Hydroxide
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