SALICYLIC ACID- medicated callus removers patch 
Cardinal Health

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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Cardinal Health ​Medicated Callus Removers

​Active ingredient

Salicylic acid 40%

Purpose

Callus remover

Use

  • for the removal of hard 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

If discomfort persists see your doctor or podiatrist

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
  • if necessary, cut medicated patch to fit callus
  • apply adhesive side down of medicated patch onto callus
  • cover medicated patch with pad
  • after 48 hours, remove medicated patch
  • 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
  • continued wearing of pad (without patch) will help prevent recurrence of calluses

Other information

store between 15°C to 30°C (59°F to 86°F)

Inactive ingredients

acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol

Questions?

call 1-866-964-0939

Principal Display Panel

LEADER

Medicated

Callus

Removers
with Salicylic Acid

  • Callus Removal Treatment
  • Protect Against Pressure & Pain

6 PADS/4 MEDICATED PATCHES

LEADER Medicated Callus Removers_v3.jpg

SALICYLIC ACID 
medicated callus removers patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-116
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID40 mg  in 4 
Inactive Ingredients
Ingredient NameStrength
POLYVINYL ALCOHOL (UNII: 532B59J990)  
VINYL ACETATE (UNII: L9MK238N77)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49781-116-104 in 1 PACKAGE; Type 0: Not a Combination Product02/01/201002/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358F02/01/201002/19/2021
Labeler - Cardinal Health (097537435)

Revised: 2/2021
Document Id: bb03e76f-569c-e78a-e053-2995a90ab62a
Set id: b2553a9f-f073-4927-b331-e8dcd63869ec
Version: 7
Effective Time: 20210210
 
Cardinal Health