Label: BLUEDOT CALLUS REMOVERS- salicylic acid patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 9, 2024

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  • Drug Facts

  • Active ingredient (in each dosage unit)

    Salicylic acid 40% in a plaster vehicle

  • Purposes

    Corn and calluses removal

  • Uses

    • For the removal of corns and calluses
    • Relieves pain by removing corns and calluses
    • Adhesive bandage holds the medicated pad in position

  • 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
    • Apply medicated bandage after 48 hours, remove medicated bandage
    • 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 0° to 40°C (32° to 104°F)

  • Inactive ingredients

    Acrylic adhesive, Titanium dioxide, Ferric hydroxide

  • Questions?

    1-800-723-2465

  • SPL UNCLASSIFIED SECTION

    • Maximum Strength

    • Medicated

    • Safe & effective callus removal treatment

    • Extra thick pads to protect against friction & reduce pressure

    DISTRIBUTED BY:
    Crest Medical Ltd.
    3 Chesford Grange,
    Warrington, Cheshire.
    WA1 4RQ. UK.

    www.crestmedical.co.uk
    MADE IN BULGARIA

  • Packaging

    CallusRmvr-1

  • INGREDIENTS AND APPEARANCE
    BLUEDOT CALLUS REMOVERS 
    salicylic acid patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84713-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID40 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC HYDROXIDE (UNII: 2UA751211N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84713-103-041 in 1 BOX09/15/2024
    14 in 1 BAG
    10.0275 g in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03009/15/2024
    Labeler - CREST MEDICAL LIMITED (238858539)
    Establishment
    NameAddressID/FEIBusiness Operations
    KRE EOOD565504983manufacture(84713-103) , label(84713-103) , pack(84713-103)
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