SALICYLIC ACID (MEDICATED CALLUS REMOVERS) PATCH [HUDSON HEALTH LLC]

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SALICYLIC ACID (MEDICATED CALLUS REMOVERS) PATCH [HUDSON HEALTH LLC]
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NDC 72446-001-08
Set ID fee137cf-48c0-4b62-b3e4-59acd504f5c3
Category HUMAN OTC DRUG LABEL
Packager Hudson Health LLC
Generic Name
Product Class
Product Number
Application Number PART358F
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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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