VISCO-GEL MEDICATED ROUND CALLUS REMOVERS (SALICYLIC ACID) DISC [PEDIFIX, INC.]

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VISCO-GEL MEDICATED ROUND CALLUS REMOVERS (SALICYLIC ACID) DISC [PEDIFIX, INC.]
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NDC 68927-0819-1
Set ID 18cc7b39-8665-4c98-9325-44422e7782f6
Category HUMAN OTC DRUG LABEL
Packager PEDIFIX, INC.
Generic Name
Product Class
Product Number
Application Number PART358F
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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   Use only as directed

    Do Not Use

    • if you are diabetic
    • on irritated, broken or infected skin
    • if you have poor blood circulation

    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 immediately.

  • Directions

    • Wash affected area. Soak in warm water for 5 minutes if desired. Dry thoroughly
    • Apply medicated disk directly over callus
    • Cover medicated disk with gel pad
    • After 48 hours, remove medicated disk
    • Repeat procedure every 48 hours as needed (until callus is removed) for up to 14 days
  • Other Information

    Store between 59° and 86°F (15° and 30°C)

  • Inactive Ingredients

    Polyvinyl Alcohol, Acrylic Copolymer

  • Questions or Comments?

    CALL: 1-800-PEDIFIX (733-4349)

  • PRINCIPAL DISPLAY PANEL - 4 Disk Blister Pack

    PediFix ®
    The Podiatrist's Choice
    Since 1885

    NEW!

    Visco-GEL ®
    Medicated Round
    Callus Removers
    With Salicylic Acid

    Instant Pain Relief!

    • Safely Removes Calluses
    • Adhesive Gel Cushions
      & Protects

    Relief
    Spot

    Maximum
    Strength

    Washable & Reusable
    Effective for Weeks

    4 Medicated Disks
    4 Cushions

    Principal Display Panel - 4 Disk Blister Pack
  • INGREDIENTS AND APPEARANCE
    VISCO-GEL MEDICATED ROUND CALLUS REMOVERS 
    salicylic acid disc
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68927-0819
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID17.67 mg  in 44.18 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    VINYL ACETATE (UNII: L9MK238N77)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68927-0819-11 in 1 CONTAINER06/01/2013
    14 in 1 CELLO PACK
    144.18 mg in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358F06/01/2013
    Labeler - PEDIFIX, INC. (122271935)
    Establishment
    NameAddressID/FEIBusiness Operations
    PEDIFIX, INC.122271935label(68927-0819) , pack(68927-0819)
    Establishment
    NameAddressID/FEIBusiness Operations
    AKRON186569323manufacture(68927-0819)
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