Other
Genital wart removal onitment
Genital Wart Removal Onitment
FDA Label NDC 84735-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hengyang Chuangjiujia Trading Co., Ltd. for the product Genital Wart Removal Onitment (NDC 84735-001). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Salicylic acid 40%
Otc - Purpose
WART REMOVAL
Indications & Usage
Use For the removal ofcommon warts. Thecommon wart is easilyrecognized by the rough"cauliflower-like" appear-ance of the surface.
Warnings
For external use onlyIf the product gets intoeyes, flush with water for15 minutes. Avoid inhalingvapours
Otc - Do Not Use
Do not use on irfitatedskinor on any area that isinfected or reddened m ifyou are diabetic or if youhave poor blood circulationm piles birthmarkssm warts with hair growingfrom them
Otc - When Using
If pregnant or breastfeed-ing, ask a health profession.al before use. Keep out ofreach of children. lfswallowed, get medical helpor contact a Poison ControlCenter right away.
Otc - Keep Out Of Reach Of Children
Keep out ofreach of children. lfswallowed, get medical helpor contact a Poison ControlCenter right away.
Otc - Stop Use
Stop use & ask a doctor ifdiscomfort persists
Dosage & Administration
Wash affected area (maysoak wart in warm waterfor 5 minutes if desired)
Dry area thoroughly.
Apply small amount byhand to covereach wart.Let dry.
Repeat this proceduretwice dailyas needed forup to 12 weeks
Inactive Ingredient
Deionized Water
Hydrogen Peroxide
Birch Oil
Petroleum
C13-14
Methyl Salicy-late
Cetearyl Alcohol
Mineral 0il
Ceteareth-20
Sodium Lauryl Sulfate
Diazolidinyl Urea
EDTA Disodium Salt
lodopropynyl Butylcarbamate
Package Label.Principal Display Panel
Label (Label)
* Please review the disclaimer below.
