DR. SCHOLLS ONE STEP CALLUS REMOVERS- salicylic acid disc 
Bayer HealthCare LLC.

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.

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Dr. Scholl's One Step Callus REMOVERS

Drug Facts

Active ingredient

Salicylic acid 40%

Purpose

Callus remover

Uses

  • for removal of calluses
  • relieves pain by removing calluses

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

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 and dry thoroughly
  • apply medicated cushion
  • after 48 hours , remove medicated cushion
  • 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

▪ Store between 20° 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

PRINCIPAL DISPLAY PANEL - 4 Disc Carton

4 Disc carton

DR. SCHOLLS  ONE STEP CALLUS REMOVERS
salicylic acid disc
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0620
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.4 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
Colorbrown (opaque solid) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-0620-14 in 1 CELLO PACK; Type 0: Not a Combination Product04/12/200510/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358F08/14/199010/31/2017
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 8/2017
Document Id: 580d5a08-eb52-ebb6-e053-2991aa0a6d3d
Set id: 3f9a6b31-1619-4d78-ae92-f397d499bf3c
Version: 5
Effective Time: 20170831
 
Bayer HealthCare LLC.