FDA Label for Satos Corn And Callus Remover

View Indications, Usage & Precautions

Satos Corn And Callus Remover Product Label

The following document was submitted to the FDA by the labeler of this product Sato Pharmaceutical Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredient

Salicylic acid 12%


Otc - Purpose



Purpose

Salicylic acid...Corn and callus remover


Indications & Usage



Uses
■ for the removal of corns and callus
■ relieves pain by removing corns


Warnings






Other Safety Information



For external use only


Environmental Warning



Flammable
■ keep away from fire or flame
■ cap bottle tightly and store at room temperature away from heat.


Otc - Do Not Use



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


Otc - When Using



When using this product
■ avoid inhaling vapors


Otc - Ask Doctor



Stop use and ask a doctor if discomfort persists.    


Otc - Keep Out Of Reach Of Children



Keep our of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.


Dosage & Administration



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 Ingredient



Inactive ingredients  collodion, lactic acid   


Package Label.Principal Display Panel



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