Label: DIO ENAMEL COATING PEN PRO TOOTH- tricalcium phosphate, dental type silica, tocopheryl acetate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated June 1, 2017

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  • ACTIVE INGREDIENT

    Tricalcium Phosphate, Dental Type Silica (Silicon Dioxide), Tocopheryl Acetate (.ALPHA.-TOCOPHEROL ACETATE)

  • PURPOSE

    For dental care

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    1. Spin the lever at the bottom of the product clockwise
    2. Rub the silicon tip smoothly on the sensitive area (60 seconds)
    3. Rinse your mouth after 30 seconds once the product is absorbed)
  • WARNINGS

    Alright container, store at room temperature (1-30)

  • INACTIVE INGREDIENT

    Sorbitol, water, etc.

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    L

  • INGREDIENTS AND APPEARANCE
    DIO ENAMEL COATING PEN PRO TOOTH 
    tricalcium phosphate, dental type silica, tocopheryl acetate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75902-6001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION20 g  in 100 g
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE0.2 g  in 100 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75902-6001-15 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2016
    Labeler - Dio Corporation (631085206)
    Establishment
    NameAddressID/FEIBusiness Operations
    KMPharmaceutical Co., Ltd.688679158manufacture(75902-6001)
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