Label: WALGREENS MEDICATED CALLUS REMOVERS- salicylic acid disc

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Salicylic acid 40%

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  • Purpose

    Callus remover

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  • Uses

    • For the removal of calluses
    • relieves pain by removing calluses
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  • 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.

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  • 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
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  • Other Information

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

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  • Inactive Ingredients

    Polyvinyl Alcohol, Acrylic Copolymer

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  • Questions or Comments?

    CALL: 1-800-925-4733

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  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

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  • PRINCIPAL DISPLAY PANEL - 4 Disk Blister Pack

    Well at
    Walgreens

    WALGREENS PHARMACIST RECOMMENDED

    NEW

    MEDICATED

    Gel Callus
    Removers

    Salicylic Acid 40%

    • Callus removal treatment
    • Cushions against pressure & pain
    • Self-sticking, washable & reusable
    • Effective for weeks

    4
    MEDICATED
    DISKS | 4 CUSHIONS

    PRINCIPAL DISPLAY PANEL - 4 Disk Blister Pack
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  • INGREDIENTS AND APPEARANCE
    WALGREENS MEDICATED CALLUS REMOVERS 
    salicylic acid disc
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-0819
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 17.67 mg
    Inactive Ingredients
    Ingredient Name Strength
    POLYVINYL ALCOHOL  
    HIGH DENSITY POLYETHYLENE  
    VINYL ACETATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0819-01 4 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part358F 06/01/2013
    Labeler - WALGREENS Co. (008965063)
    Registrant - PEDIFIX, INC. (122271935)
    Establishment
    Name Address ID/FEI Business Operations
    AKRON 186569323 MANUFACTURE(0363-0819)
    Establishment
    Name Address ID/FEI Business Operations
    PEDIFIX 122271935 PACK(0363-0819), LABEL(0363-0819)
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