FREEZONE (SALICYLIC ACID) LIQUID [MEDTECH PRODUCTS INC.]

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FREEZONE (SALICYLIC ACID) LIQUID [MEDTECH PRODUCTS INC.]
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NDC 63029-104-03
Set ID f55b64b3-d87d-4c96-9a73-96325059e6b8
Category HUMAN OTC DRUG LABEL
Packager Medtech Products Inc.
Generic Name
Product Class
Product Number
Application Number PART358F
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Salicylic acid 17.6% in a flexible collodion base

  • Purpose

    Corn/Callus Remover

  • Use

    For the removal of corns and calluses

  • Warnings

    For external use only.

    • Extremely flammable. Keep away from fire or flame.
    • Cap bottle tightly and store at room temperature away from heat.

    Do not use this product

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

    Stop use and ask a doctor if

    discomfort persists

    When using this product

    • avoid inhaling vapors
    • avoid contact with eyes. If product gets into the eye, flush with water for 15 minutes.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • Wash affected area.
    • You may soak callus or corn in warm water for 5 minutes.
    • Dry area thoroughly
    • Apply one drop at a time to cover each corn or callus.
    • Let dry.
    • Repeat procedure once or twice daily as needed for up to 14 days (until corn or callus is removed).
  • Inactive Ingredients

    alcohol 27%, ether 57%

  • Questions?

    1-800-443-4908

  • Freezone® Liquid Corn & Callus Remover, 0.3 fl oz (9 mL)

    Freezone Liquid Corn and Callus Remover Carton

  • INGREDIENTS AND APPEARANCE
    FREEZONE 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID158.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ETHER (UNII: 0F5N573A2Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-104-031 in 1 BOX10/01/1999
    19 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358F10/01/1999
    Labeler - Medtech Products Inc. (122715688)
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