Otc - Active Ingredient
Salicylic Acid 2.6%
Genital Wart Remover Cream
FDA Label NDC 85157-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shanghai Yijing Medical Technology Co., Ltd. for the product Genital Wart Remover Cream (NDC 85157-001). 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, otc - keep out of reach of children, indications & usage, warnings, otc - when using, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Wart Remover
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN SECTION
Indications & Usage
for the removal of genital, plantar common, and flat wartse
the common wart is easily recognized by the rough "cauliflower-like
appearance ot the surtaceāthe 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.
Keep away trom tire and tlame.
Otc - When Using
avoid contact with eyes. lf the product gets into the eye, flush with water for 15 minutes
avoid inhaling vapors
cap the tube tightlye
out of direct sunlight and store at room temperature away from heat
Dosage & Administration
wash the affected area
may soak the wart in warm water for 5 minutes
dry area thoroughly
using the applicator (cotton swab), apply a layer of ointment to sufficientlycover each wart
allow it to fully absorb and cover it with a bandage as needed
repeat this procedure once or twice daily as needed (until the wart is removed)for up to 12 weeks
Inactive Ingredient
WATER, MENTHOL, (+)-
Package Label.Principal Display Panel
Label1 (Label1)
Label2 (Label2)
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