Active Ingredient
Salicylic Acid 40%
Supreh Solid Wart Remover Stick
FDA Label NDC 83818-027
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Xinxin Yunhai Technology Co., Ltd. for the product Supreh Solid Wart Remover Stick (NDC 83818-027). 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 and ask a doctor if, 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 warts. The common wart is easily recognized by the rough “cauliflower-like” appearance of the surface.
For the removal of plantar warts. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern.
Warnings
For external use only
Do Not Use
If you are a diabetic
On irritated, infected, or reddened skin
If you have poor blood circulation
On warts with hair growing from them
On moles or birthmarks
On face, genitals or mucous membranes
When Using
avoid contact with eyes, mucous membranes, and face.
if product gets into eyes, flush with water for 15 minutes.
use only as directed.
if discomfort persists, see a doctor.
cap the stick tightly after use to prevent drying.
Stop Use And Ask A Doctor If
irritation occurs or if discomfort persists
Ask Doctor
before use if you have
diabetes.
poor blood circulation.
any other serious skin conditions in the area being treated.
Keep Out Of Reach Of Children
Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Wash affected area
May soak wart in warm water for 15 minutes
Dry area thoroughly
Apply thin layer of the product to each wart
Cover affected area with clean bandage
Repeat procedure daily as needed (until wart is removed) for up to 12 weeks
Other Information
Replace cap when finished and stored at room temperature
Inactive Ingredients
Petrolatum, Castor Oil, White Beeswax, Diisostearyl Malate, Microcrystalline Wax, Synthetic Wax
Questions
Please contact [email protected]
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