Label: MASTIKIS MASTIC 24K- silicon dioxide, aminocaproic acid paste, dentifrice

  • NDC Code(s): 79814-003-01, 79814-003-02
  • 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 14, 2020

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

  • ACTIVE INGREDIENT

    Aminocaproic Acid 0.1%
    Silica 16%

  • INACTIVE INGREDIENT

    D-Sorbitol Solution, Glycerin, Polyethylene Glycol1500, Carboxymethylcellulose Sodium, Hydroxyapatite, Sodium Bicarbonate, Bamboo salt, Xylitol, Steviol Glycoside, L-Menthol, Grapefruit Seed Extract, Mastic Oil, Olive Oil, Phytonside flavour, Glycyrrhiza Extract, Sodium Lauroyl Sarcosinate, Sodium Cocoyl Glutamate, Deionized Water

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of Reach of Children.

  • PURPOSE

    Anti-cavity

    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 
    silicon dioxide, aminocaproic acid paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79814-003
    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)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    XYLITOL (UNII: VCQ006KQ1E)  
    STEVIOSIDE (UNII: 0YON5MXJ9P)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    LICORICE (UNII: 61ZBX54883)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79814-003-021 in 1 CARTON08/14/2020
    1NDC:79814-003-01110 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/14/2020
    Labeler - Mastic Korea.Co.Ltd (687791189)
    Registrant - Mastic Korea.Co.Ltd (687791189)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sungwon Pharmaceutical Co., Ltd.689787898manufacture(79814-003)