Label: MASTIKIS GOLD II- silicon dioxide, tetrasodium pyrophosphate paste, dentifrice

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

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Drug Label Information

Updated August 13, 2020

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  • ACTIVE INGREDIENT

    Silicon Dioxide 14.0%
    Tetrasodium Pyrophosphate 0.5%

  • INACTIVE INGREDIENT

    Tocopherol Acetate, D-Sorbitol Solution, Glycerin, Polyethylene Glycol1500, Carboxymethylcellulose Sodium, Trisodium Citrate, Xylitol, Steviol Glycoside, Bioactive Herb Complex-C(BHC-C), Hydroxyapatite, L-Menthol, Mastic oil, Grapefruit Seed Extract, Sodium Lauroyl Sarcosinate, Sodium Cocoyl Glutamate, Deionized Water

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of Reach of Children.

  • PURPOSE

    Anti-plaque

  • WARNINGS

    Ask a dentis before use if you have

    - bleeding or redness lasting more than 2 weeks pain, welling, pus, loose teeth, or more spacing between teeth.

    - These may be signs of periodontis, a serious from of gum disease

  • INDICATIONS & USAGE

    Brighter and healthier teeth and better oral hygine

    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 GOLD II 
    silicon dioxide, tetrasodium pyrophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79814-002
    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
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ) SODIUM PYROPHOSPHATE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    XYLITOL (UNII: VCQ006KQ1E)  
    STEVIOSIDE (UNII: 0YON5MXJ9P)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79814-002-021 in 1 CARTON08/13/2020
    1NDC:79814-002-01120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/13/2020
    Labeler - Mastic Korea.Co.Ltd (687791189)
    Registrant - Mastic Korea.Co.Ltd (687791189)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sungwon Pharmaceutical Co., Ltd.689787898manufacture(79814-002)
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