Label: MASTIKIS GOLD II- silicon dioxide, 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 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)