Label: SALICYLIC ACID- callus removers patch

  • NDC Code(s): 56104-244-01
  • Packager: Premier Brands of America Inc.
  • Category: HUMAN OTC DRUG LABEL

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 25, 2023

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  • ​Active ingredient

    Salicylic acid 40%

  • Purpose

    Callus remover

  • Use

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

    For external use only.

    Do not use

    • if you are a diabetic
    • have poor blood circulation
    • on irritated skin, on any area that is infected or reddened

    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
    • carefully adhere medicated patch directly over 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°F to 86°F)

  • Inactive ingredients

    acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol

  • Questions?

    call 1-866-964-0939

  • Principal Display Panel

    Premier

    CALLUS REMOVERS

    Salicylic Acid

    Effective callus removal treatment

    Protects against pressure & friction

    MEDICATED

    6 PADS/4 MEDICATED PATCHES

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  • INGREDIENTS AND APPEARANCE
    SALICYLIC ACID 
    callus removers patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-244
    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:56104-244-014 in 1 PACKAGE; Type 0: Not a Combination Product06/16/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358F06/16/2022
    Labeler - Premier Brands of America Inc. (117557458)
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