DR. SCHOLLS EXTRA THICK CALLUS REMOVERS (SALICYLIC ACID) DISC [BAYER HEALTHCARE LLC.]

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  • DR. SCHOLLS EXTRA THICK CALLUS REMOVERS (SALICYLIC ACID) DISC [BAYER HEALTHCARE LLC.]

DR. SCHOLLS EXTRA THICK CALLUS REMOVERS (SALICYLIC ACID) DISC [BAYER HEALTHCARE LLC.]
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NDC 11523-0463-1
Set ID 1f1d9d83-3b81-4f4b-9893-940d05f68ba3
Category HUMAN OTC DRUG LABEL
Packager Bayer HealthCare LLC.
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 removal of calluses
    • relieves pain by removing calluses
  • Warnings

    For external use only

    Do not use

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

    Stop use and ask a doctor if discomfort lasts

    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 disc to fit callus

    ▪ apply medicated disc with sticky side adhering to skin

    ▪ cover medicated disc with enclosed cushion

    ▪ after 48 hours, remove medicated disc

    ▪ 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 20° to 25°C (68° to 77°F).

    ▪ Protect from excessive heat (temperatures above 40°C (104°F)).

  • Inactive ingredients

    antioxidant (CAS 991-84-4), iron oxides, mineral oil, petroleum hydrocarbon resin, silicon dioxide, synthetic polyisoprene rubber, talc

  • Questions?

    1-866-360-3226

  • PRINCIPAL DISPLAY PANEL - 4 Medicated Disks Cello Pack

    4 Disc cello pack

  • INGREDIENTS AND APPEARANCE
    DR. SCHOLLS  EXTRA THICK CALLUS REMOVERS
    salicylic acid disc
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0463
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.4 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorbrown (opaque solid) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0463-14 in 1 CELLO PACK; Type 0: Not a Combination Product04/12/200511/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358F08/14/199011/30/2021
    Labeler - Bayer HealthCare LLC. (112117283)
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