Label: PED X CALLUS REMOVERS, EXTRA THICK MEDICATED- salicylic acid patch
PED X CALLUS REMOVERS, MEDICATED- salicylic acid 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 October 17, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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

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

    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 disk to fit callus before applying.
    • after 48 hours remove the medicated disk.
    • repeat this 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 59°F-86°F (15°C-30°C)
  • Inactive ingredient

    Vinyl acetate.

  • Questions?

    1(541)-476-3178, 8 am to 5 pm (M–F), PST

  • PRINCIPAL DISPLAY PANEL - 4 mg Patch Cello Pack - Extra Thick

    pedx

    new!

    Extra Thick Medicated

    Callus Removers

    dissolving relief from tough

    CALLUSES

    6 cushions
    4 medicated disks

    Principal Display Panel - 4 mg Patch Cello Pack - Extra Thick
  • PRINCIPAL DISPLAY PANEL - 4 mg Patch Cello Pack - Medicated

    pedx

    new!

    Medicated

    Callus Removers

    dissolving relief from tough

    CALLUSES

    6 cushions
    4 medicated disks

    Principal Display Panel - 4 mg Patch Cello Pack - Medicated
  • INGREDIENTS AND APPEARANCE
    PED X CALLUS REMOVERS, EXTRA THICK MEDICATED 
    salicylic acid patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60193-401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic acid (UNII: O414PZ4LPZ) (Salicylic acid - UNII:O414PZ4LPZ) Salicylic acid4 mg
    Inactive Ingredients
    Ingredient NameStrength
    Vinyl acetate (UNII: L9MK238N77)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60193-401-024 in 1 CELLO PACK
    1NDC:60193-401-011 in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358F09/01/2007
    PED X CALLUS REMOVERS, MEDICATED 
    salicylic acid patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60193-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic acid (UNII: O414PZ4LPZ) (Salicylic acid - UNII:O414PZ4LPZ) Salicylic acid4 mg
    Inactive Ingredients
    Ingredient NameStrength
    Vinyl acetate (UNII: L9MK238N77)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60193-400-024 in 1 CELLO PACK
    1NDC:60193-400-011 in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358F09/01/2007
    Labeler - Pacific World Corporation (089693097)