Label: SALICYLIC ACID- medicated callus removers patch

  • NDC Code(s): 70000-0333-1
  • Packager: LEADER/ Cardinal Health 110, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 21, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • ​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 40%

    • Effective Callus Removal Treatment
    • Protect Against Pressure and Pain
    • 4 MEDICATED PATCHES/ 6 PROTECTIVE PADS

    Leader Callus Remover

  • INGREDIENTS AND APPEARANCE
    SALICYLIC ACID 
    medicated callus removers patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0333
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID400 mg  in 1 g
    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:70000-0333-14 in 1 CARTON02/21/2018
    11 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03002/21/2018
    Labeler - LEADER/ Cardinal Health 110, Inc. (063997360)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!