Label: MASTIKIS GOLD- silicon dioxide, aminocaproic acid paste, dentifrice

  • NDC Code(s): 79814-001-01, 79814-001-02
  • Packager: Mastic Korea.Co.Ltd
  • Category: HUMAN OTC DRUG LABEL

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 July 31, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Aminocaproic Acid 0.1%
    Silica 16%

  • INACTIVE INGREDIENT

    D-Sorbitol Solution, Deionized Water, Glycerin, Mastic oil, Sodium Lauryl Sulfate, Polyethylene Glycol1500, Carboxymethylcellulose Sodium, Grapefruit Seed Extract, Xylitol, Steviol Glycoside, Hydroxyapatite, L-Menthol, Ascorbic Acid, Tocopherol Acetate

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of Reach of Children.

  • PURPOSE

    Anti-cavity

    Anti-plaque

  • WARNINGS

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Aids in the cleanness of teeth and protection of gum health

  • DOSAGE & ADMINISTRATION

    Supervise children as necessary until capable of using without supervision.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MASTIKIS GOLD 
    silicon dioxide, aminocaproic acid paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79814-001
    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)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    XYLITOL (UNII: VCQ006KQ1E)  
    STEVIOSIDE (UNII: 0YON5MXJ9P)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79814-001-021 in 1 CARTON07/31/2020
    1NDC:79814-001-01120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/31/2020
    Labeler - Mastic Korea.Co.Ltd (687791189)
    Registrant - Mastic Korea.Co.Ltd (687791189)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sungwon Pharmaceutical Co., Ltd.689787898manufacture(79814-001)