Label: SALICYLIC ACID- callus removers patch

  • NDC Code(s): 56104-013-04
  • Packager: Premier Brands of America Inc.
  • 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 26, 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 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

    Premier

    CALLUS REMOVERS

    Salicylic Acid

    Effective callus removal treatment

    Protects against pressure & friction

    MEDICATED

    6 PADS/4 MEDICATED PATCHES

    callus Removers

  • INGREDIENTS AND APPEARANCE
    SALICYLIC ACID 
    callus removers patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-013
    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:56104-013-044 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358F01/01/2013
    Labeler - Premier Brands of America Inc. (117557458)
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