Otc - Active Ingredient
Salicylic Acid 40%
Wart Remover Patch
FDA Label NDC 87255-004
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 Mengyue Technology Co., Ltd. for the product Wart Remover (NDC 87255-004). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, 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
Wart Remover
Indications & Usage
Use
For the removal of common warts. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface.
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
•On irritated, infected or reddened skin
•On genital warts and warts on the face
•On moles, birthmarks and warts with hair growing from them
•On mucous membranes
Otc - When Using
When using
Ask a doctor before use if you have diabetes or poor blood circulation.
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
Directions
·Wash affected area may soak wart in warm water for 5 minutes
·Dry area thoroughly
·Remove bandage strips by peeling back off
·If necessary, cut medicated patch to fit wart
·Carefully apply medicated plaster
·Repeat procedure every 48 hours as needed(until wart is removed) for up to 12 weeks
Dosage&administration section
One patch per day, each patch contains 12 mg of salicylic acid.
Storage And Handling
Other information
Store between 59° and 86°F (15° and 30° C).
Inactive Ingredient
Inactive ingredientsHard paraffin, lanolin, phenol, borneol, crocus sativus L, gleditsia sinensis Lam
Package Label.Principal Display Panel
87255-004-01 (87255 004 01)
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