Otc - Active Ingredient
Active Ingredient
Salicylic Acid 5%
Purpose
Wart remover
Wart Remover Pen Liquid
FDA Label NDC 87365-003
8 label sections · Submitted to the FDA by Jiangxi He-oumei Health Industry Co., Ltd. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi He-oumei Health Industry Co., Ltd. for the product Wart Remover Pen (NDC 87365-003). 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, warnings, dosage & administration, indications & usage, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
For removal of common warts
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Contr
ol Center immediately.
Warnings
Warnings
For external use only.
Do not use on:
Moles, Birthmarks, Warts with hair growing from them,
Genital warts. Warts on the face
Irritated or infected skin
Ask a doctor before use if you have:Diabetes, Poor blood
circulation,Immune system problems
When using this product:Avoid contact with eyes, Avoid
contact with healthy skin.
Stop use and ask a doctor if:Severe irritation occurs., Co
ndition worsens.
Dosage & Administration
Apply once or twice daily until wart is removed.
Do not use for more than 12 weeks unless directed by
adoctor.
Indications & Usage
Directions
1.Clean affected area and dry thoroughly.
2.Open the cap and twist the pen tip gently until liqui
d appears.
3. Apply only to the wart.
4. Avoid contact with surrounding healthy skin.
5. Allow to dry after application.
6. Apply once or twice daily until wart is removed.
Do not use for more than 12 weeks unless directed by
adoctor.
Inactive Ingredient
Inactive Ingredients
Ethanol, Propylene Glycol, Castor Oil, Camphor, Purified
Water
Package Label.Principal Display Panel
Labeling (87365 003 01)
Labeling (87365 003 01)
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