Otc - Active Ingredient
Active ingredient
Salicylic acid 30%
Purpose Wart remove
Maximum Strength Wart Remover Patches Patch
FDA Label NDC 85136-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Henan Toudaorong Biotechnology Co., Ltd. for the product Maximum Strength Wart Remover Patches (NDC 85136-011). 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 - keep out of reach of children, otc - purpose, warnings, inactive ingredient, indications & usage, dosage & administration, 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 - Keep Out Of Reach Of Children
Keep out of reach of children. lf swallowed, get medical help or contact aPoison Control Center (1-800-222-1222)right away.
Otc - Purpose
For the removal of common warts and plantar warts.Common warts arerough, cauliflower-like growths often on fingers/hands. Plantar wartsoccur on the soles of feet.
Warnings
Warnings
Do not use on face, genital warts, moles with hair, or irritated/reddened skin
Inactive Ingredient
Inactive ingredients Cellulose Gum, Propylene Glycol, Cyclodextrin, MelaleucaAlternifolia (Tea Tree) Leaf Oil, Centella Asiatica Extract, Polvisobutene.Hvdroxvethylcelulose,Disodium Phosphate, polysorbate 60
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Indications & Usage
on irritated skin or any area that is infected or reddened"
on moles, birthmarks, warts with hair growing from them, genital warts, or wartson the face or mucous membranes,
Dosage & Administration
Directions
wash afected areadry area thoroughly apply the patch directly over the wart or tagrepeat this procedure every 48 hours as needed, until the wart or tag is removedfå´§or up to 12 weeks"Apply the procedure every 48 hours, up to 12 weeks, until the wart isremoved.
Package Label.Principal Display Panel
85136-011-01 (85136 011 01)
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