Otc - Active Ingredient
Active ingredient
Salicylic acid 12%
The following Structured Product Label (SPL) was submitted to the FDA by Sato Pharmaceutical Co., Ltd. for the product Satos Corn And Callus Remover (NDC 49873-078). 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, indications & usage, warnings, other safety information, environmental warning, otc - do not use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient
Salicylic acid 12%
Purpose
Salicylic acid...Corn and callus remover
Uses
■ for the removal of corns and callus
■ relieves pain by removing corns
For external use only
Flammable
■ keep away from fire or flame
■ cap bottle tightly and store at room temperature away from heat.
Do not use
■ on irritated skin
■ on any area that is infected or reddened
■ if you are a diabetic
■ if you have poor blood circulation
When using this product
■ avoid inhaling vapors
Stop use and ask a doctor if discomfort persists.
Keep our of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
■ wash affected area and dry thoroughly
■ apply one drop at a time with applicator to sufficiently cover each corn/callus
■ let dry
■ repeat this procedure once or twice daily as needed for up to 14 days (until corn/callus is removed)
■ may soak corn/callus in warm water for 5 minutes to assist in removal
Inactive ingredients collodion, lactic acid
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