Label: MASTIKIS MASTIC GUMCARE- silicon dioxide, aminocaproic acid paste, dentifrice

  • NDC Code(s): 79814-009-01, 79814-009-02
  • Packager: Mastic Korea.Co.Ltd
  • 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 10, 2021

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

  • ACTIVE INGREDIENT

    Silicon Dioxide 16%

    Aminocaproic Acid 0.1%

  • INACTIVE INGREDIENT

    D-Sorbitol Solution, Glycerin, Carboxymethylcellulose Sodium, Corn Starch, Xylitol, Steviol Glycoside, Sodium Ascorbate, Hydroxyapatite, Sodium Bicarbonate, L-Menthol, Mastic Oil, Mentha Oil, Olive Oil, Eucalyptus Oil, Grapefruit Seed Extract, Glycyrrhiza Extract, Sodium Cocoyl Glutamate, Sodium Lauroyl Sarcosinate, Deionized Water

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of Reach of Children.

  • PURPOSE

    Anti-cavity

    Anti-gingivitis

  • 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

    - Healthier teeth and gums, 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 GUMCARE 
    silicon dioxide, aminocaproic acid paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79814-009
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE16 g  in 100 g
    AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) AMINOCAPROIC ACID0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    XYLITOL (UNII: VCQ006KQ1E)  
    STEVIOSIDE (UNII: 0YON5MXJ9P)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    LICORICE (UNII: 61ZBX54883)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79814-009-021 in 1 CARTON08/10/2021
    1NDC:79814-009-01120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/10/2021
    Labeler - Mastic Korea.Co.Ltd (687791189)
    Registrant - Mastic Korea.Co.Ltd (687791189)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sungwon Pharmaceutical Co., Ltd.689787898manufacture(79814-009)