Drug Facts
Drug Facts
Scholls Wellness Company Llc Disc
FDA Label NDC 73469-0463
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Scholls Wellness Company Llc for the product Scholls Wellness Company Llc (NDC 73469-0463). 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 drug facts, active ingredient, purpose, uses, warnings, 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.
Label Section Quick Index
Active Ingredient
Active Ingredient Purpose
Salicylic Acid 40%..........Callus remover
Purpose
Callus remover
Uses
Uses
for the removal of calluses
relieves pain by removing calluses
Warnings
Warnings
For external use only
Do Not Use
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
Stop Use And Ask A Doctor
Stop use and ask a doctor if discomfort lasts
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Directions
wash affected area and dry thoroughly
if necessary, cut medicated disc to fit callus
apply medicated disc with sticky side adhering to skin
cover medicated disc with enclosed cushion
after 48 hours, remove medicated disc
repeat procedure every 48 hours as needed for up to 14 days (until callus is removed)
may soak callus in warm water for 5 minutes to assist in removal
Other Information
Other Information
Store between 20°C to 25°C (68° to 77°F). Protect from excessive heat above 40°(104°F).
Inactive Ingredient
antioxidant (CAS 991-84-4), iron oxides, mineral oil, petroleum hydrocarbon resin, silicon dioxide, synthetic polyisoprene rubber, talc
Otc - Questions
Questions? 1-866-360-3226
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