Label: SALICYLIC ACID- extra thick callus remover patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated January 19, 2023

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

  • Active ingredient

    Salicylic Acid 40%

  • Purpose

    Callus Remover

  • Uses

    • for the removal of calluses
    • relieves pain by removing calluses
  • Warnings

    For external use only.

    Do noy use

    • if you are 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 persists

    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
  • Other information

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

  • Inactive ingredients

    acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol

  • Questions?

    call 1-866-964-0939

  • Principal Display Panel

    Harmon FaceValues

    EXTRA THICK

    Callus Removers

    Salicylic Acid

    MAXIMUM STRENGTH

    Removes Calluses Safely & Effectively

    Extra thick pad relieves pain & protects callus all day

    4 PADS

    4 MEDICATED PATCHES

    Harmon Extra Thick Callus Remover.jpg

  • INGREDIENTS AND APPEARANCE
    SALICYLIC ACID 
    extra thick callus remover patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-010
    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:63940-010-044 in 1 PACKAGE; Type 0: Not a Combination Product02/18/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358F02/18/2014
    Labeler - Harmon Store Inc. (804085293)