Label: SALICYLIC ACID- medicated callus removers patch

  • 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 July 20, 2021

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  • 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 not use

    • if you are a diabetic
    • have poor blood circulation
    • on irritated skin, on 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 thoroughlyif 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°F to 86°F)

  • Inactive ingredients

    acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol

  • Questions?

    call 1-877-237-0194

  • Principal Display Panel

    comfortzone

    medicated

    callus remvoers

    salicylic acid

    • effective callus removal treatment
    • protects against pressure & friction

    12 pads/ 8 medicated patches

    Amazon_Callus Removers_52-005AM.jpg

  • INGREDIENTS AND APPEARANCE
    SALICYLIC ACID 
    medicated callus removers patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72446-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID40 mg  in 8 
    Inactive Ingredients
    Ingredient NameStrength
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    VINYL ACETATE (UNII: L9MK238N77)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72446-001-088 in 1 PACKAGE; Type 0: Not a Combination Product08/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358F08/31/2018
    Labeler - Hudson Health LLC (081276171)
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