Label: MASTIKIS QINGJIE SHINE MASTIC- silicon dioxide, tocopherol acetate, tetrasodium pyrophosphate paste, dentifrice

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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, Polyethylene Glycol1500, Carboxymethylcellulose Sodium, Hydroxyapatite, Trisodium Citrate, Bamboo salt, Xylitol, Steviol Glycoside, Bioactive Herb Complex-C(BHC-C), Propolis Extract, L-Menthol, Grapefruit Seed Extract, Mastic Oil, Glycyrrhiza Extract, Eucalyptus Oil, Sodium Lauroyl Sarcosinate, 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
    MASTIKIS QINGJIE SHINE MASTIC 
    silicon dioxide, tocopherol acetate, tetrasodium pyrophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79814-004
    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)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    XYLITOL (UNII: VCQ006KQ1E)  
    STEVIOSIDE (UNII: 0YON5MXJ9P)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    LICORICE (UNII: 61ZBX54883)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79814-004-021 in 1 CARTON09/14/2020
    1NDC:79814-004-01120 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(79814-004)
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