Label: MASTIKIDS II- silicon dioxide, tocopherol acetate, tetrasodium pyrophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated September 14, 2020

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  • ACTIVE INGREDIENT

    Silicon Dioxide 14%

    Tocopherel Acetate 0.1%

    Tetrasodium Pyrophosphate 0.5%

  • INACTIVE INGREDIENT

    D-Sorbitol Solution, Glycerin, Carboxymethylcellulose Sodium, Trisodium Citrate, Xylitol, Steviol Glycoside, Hydroxyapatite, L-Menthol, Strawberry Flavor, Mastic Oil, Eucalyptus Oil, Grapefruit Seed Extract, Propolis Extract, Green Tea Extract, Aloe Extract, Sodium Cocoyl Glutamate, Deionized Water

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of Reach of Children.

  • PURPOSE

    Anti-gingivitis

    Anti-plaque

  • WARNINGS

    Ask a dentist before use if you have

    - bleeding or redness lasting more than 2 weeks pain, swelling, pus, losse teeth, or more spacing between teeth

    - These may be signs of periodontitis, a serious form of gum disease

  • INDICATIONS & USAGE

    - Brighter and healthier teeth and better oral hygiene

    - Anti-caries, anti-plaque, anti--gingivitis

    - Prevents periodontal and gum disease

  • DOSAGE & ADMINISTRATION

    Brush teeth with a pea-sized amount

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MASTIKIDS II 
    silicon dioxide, tocopherol acetate, tetrasodium pyrophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79814-005
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE14 g  in 100 g
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE0.1 g  in 100 g
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ) SODIUM PYROPHOSPHATE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    XYLITOL (UNII: VCQ006KQ1E)  
    STEVIOSIDE (UNII: 0YON5MXJ9P)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    STRAWBERRY (UNII: 4J2TY8Y81V)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALOE (UNII: V5VD430YW9)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79814-005-021 in 1 CARTON09/14/2020
    1NDC:79814-005-0170 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/14/2020
    Labeler - Mastic Korea.Co.Ltd (687791189)
    Registrant - Mastic Korea.Co.Ltd (687791189)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sungwon Pharmaceutical Co., Ltd.689787898manufacture(79814-005)
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