Satos Corn and Callus Remover

Dosage form: liquid
Ingredients: SALICYLIC ACID 12g in 100mL
Labeler: Sato Pharmaceutical Co., Ltd.
NDC Code: 49873-078

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

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

WARNINGS



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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SATOS CORN AND CALLUS REMOVER 
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-078
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID12 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PYROXYLIN 
LACTIC ACID 
Packaging
#Item CodePackage Description
1NDC:49873-078-011 BOTTLE (BOTTLE) in 1 CARTON
19.85 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358F09/19/1987
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIOperations
Sato Pharmaceutical Co., Ltd.715699133manufacture, label, pack

Revised: 03/2012
 
Sato Pharmaceutical Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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