DR. SCHOLLS DURAGEL CALLUS REMOVERS (SALICYCLIC ACID) DISC [BAYER HEALTH CARE LLC.]

DR. SCHOLLS DURAGEL CALLUS REMOVERS (SALICYCLIC ACID) DISC [BAYER HEALTH CARE LLC.]
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NDC 11523-0644-1
Set ID 2e5502e5-5f7d-2666-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Bayer Health Care LLC.
Generic Name
Product Class
Product Number
Application Number PART358F
  • Drug Facts

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Salicylic acid 40%

  • PURPOSE

    Callus remover

  • Uses

    Uses

    ▪ for the removal of calluses

    ▪ relieves pain by removing calluses

  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    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

    Stop use and ask a doctor if discomfort lasts

  • When using

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    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

    Other information

    ▪ Store between 20° to 25°C (68° to 77°F).

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

  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • QUESTIONS

    Questions? 1- 866-360-3226

  • 1 pack disc carton

    Dr. Scholls Duragel Callus Removers

  • INGREDIENTS AND APPEARANCE
    DR. SCHOLLS DURAGEL CALLUS REMOVERS 
    salicyclic acid disc
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0644
    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
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0644-11 in 1 CARTON02/01/201606/30/2022
    14 in 1 CELLO PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358F02/01/201606/30/2022
    Labeler - Bayer Health Care LLC. (112117283)

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