Label: MASTIKIS MASTIC 24K WHITENING- hydrogen peroxide solution, tocopherol acetate, colloidal silicon dioxide 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 January 28, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Colloidal Silicon Dioxide 7%

    Hydrogen Peroxide Solution 2.14%

    Tocopherol Acetate 0.2%

  • INACTIVE INGREDIENT

    D-Sorbitol Solution, Water, Glycerin, Mastic Oil, PCarboxymethylcellulose Sodium, Xantahan Gum, Polysorbate 60, Titanium Oxide, Citric Acid, Zylitol, Steviol Glycoside, Grapefruit Seed Extract, Sodium Lauroyl Sarcosinate, Sodium Cocoyl Glutamate, Mentha Oil, Spearmint oil, Tocopherol Acetate, Hydroxyapatite, L-Menthol, Eucalyptus Oil, Phytonside flavour, Glycyrrhiza Extract

  • 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 MASTIC 24K WHITENING 
    hydrogen peroxide solution, tocopherol acetate, colloidal silicon dioxide paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79814-008
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE2.14 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 DIOXIDE7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XYLITOL (UNII: VCQ006KQ1E)  
    STEVIOSIDE (UNII: 0YON5MXJ9P)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LICORICE (UNII: 61ZBX54883)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79814-008-021 in 1 CARTON01/28/2021
    1NDC:79814-008-01110 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/28/2021
    Labeler - Mastic Korea.Co.Ltd (687791189)
    Registrant - Mastic Korea.Co.Ltd (687791189)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sungwon Pharmaceutical Co., Ltd.689787898manufacture(79814-008)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!