Warnings
Warnings For external use only.
Wart Remover Patch
FDA Label NDC 84019-046
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shengnan (guangzhou) Cosmetics Co., Ltd for the product Wart Remover (NDC 84019-046). 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 warnings, otc - purpose, otc - stop use, otc - active ingredient, otc - when using, inactive ingredient, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
For the removal of common warts. Common warts are easily recognized by the rough, cauliflower-like appearance of the surface.
Otc - Stop Use
· on irritated, infected or reddened skin
· on genital warts and on the face
· on moles, birthmarks, or warts with hair growing from them
·on mucous membranes
Otc - Active Ingredient
Salicylic Acid
Otc - When Using
When using
Ask a doctor before use if you have diabetes or poor
blood circulation.
Inactive Ingredient
Hard paraffin, lanolin, Tea Tree Oil, Aloe Vera, Vitamin E, Glycerin,
Centella Asiatica.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Repeat these steps two to three
times daily as needed (until the
wart is removed)for up to 12 weeks.
Indications & Usage
Directions
Wash affected area. Soak wart in warm water for 5 minutes if needed.Dry area thoroughly. Remove backing. Cut medicated patch to fit wart if necessary. Carefully apply medicated plaster. Repeat every 48 hours as needed for up to 12 weeks.
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