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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Scholls Wellness Company Llc for the product Scholls Wellness Company Llc (NDC 73469-0631). 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, purpose, uses, warnings, otc - do not use, stop use and ask a doctor, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Active Ingredient Purpose
Salicylic Acid 40%.......................Wart remover
Wart remover
Uses
for the removal of plantar warts. The plantar wart is recognized by its location only on teh bottom of the foot, its tenderness, and the interuption of the footprint pattern.
Warnings
For external use only
Do not use
if you are a diabetic
if you have poor blood circulation
on irritated skin or any area that is infected or reddened
on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes.
Stop use and ask a doctor if discomfort lasts
Keep out of reach of children. If swallowed,
get medical help or contact a Poison Control Center right away.
Directions
wash affected area
may soak wart in warm water for 5 minutes
dry area thoroughly
if necessary, cut medicated disc to fit wart
apply medicated disc, dark sticky side on skin, directly over wart
cover medicated disc with enclosed cushion
repeat procedure every 48 hours as needed (until wart is removed) for up to 12 weeks
Other information
store between 20°C to 25°C (68° to 77°F). Protect from excessive heat (temperatures above 40°C (104°F)
Inactive ingredients antioxidant
(CAS 991-84-4), iron oxides, mineral oil,
petroleum hydrocarbon resin, silicon dioxide,
synthetic polyisoprene rubber, talc
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