Otc - Active Ingredient
SALICYLIC ACID 40%
Genital Wart Removal Onitment Cream
FDA Label NDC 87278-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangxi Keyun E-commerce Co., Ltd. for the product Genital Wart Removal Onitment (NDC 87278-011). 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 - stop use, 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 Remove
Indications & Usage
Use For the removal of common warts. The common wart is easily recognized by the rough"cauliflower-like" appear-ance of the surface.
Warnings
For external use only If the product gets into eyes, flush with water for 15 minutes. Avoid inhaling vapours.
Otc - Do Not Use
Do not use on irfitated skinor on any area that is infected or reddened m if you are diabetic or if you have poor blood circulationm piles birthmarkssm warts with hair growing from them
Otc - Stop Use
Stop use & ask a doctor if discomfort persists
Otc - Keep Out Of Reach Of Children
If pregnant or breastfeed-ing, ask a health profession-al before use. Keep out of reach of children. Ifswallowed, get medical helpor contact a Poison ControlCenter right away.
Dosage & Administration
Wash affected area (may soak wart in warm water for 5 minutes if desired)
Dry area thoroughly.
Apply small amount by hand to covereach wart.
Let dry.
Repeat this procedure twice dailyas needed for up to 12 weeks
Inactive Ingredient
HYDROGEN PEROXIDE
B ETULA PENDULA TAR OIL
MINERAL OIL
WATER
C 13-14 ISOPARAFFIN
IO DO PROPYNYL BUTYLCARBAMATE
METHYL SALICYLATE
LIQUID PETROLEUM
DIAZOLIDINYL UREA
EDETATE DISODIUM
CETOSTEARYL ALCOHOL
POLYOXYL 20 CETOSTEARYL ETHER
SODIUM LAURYL SULFATE
Package Label.Principal Display Panel
Label (Label)
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