Label: GREENSALTRAIN TOOTH- precipitated calcium carbonate, dibasic calcium phosphate, aminocaproic acid, aluminium chlorohydroxy allantoinate paste, dentifrice

  • NDC Code(s): 74724-0030-1
  • Packager: K.Boeun Pharmaceutical 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 November 30, 2021

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

  • ACTIVE INGREDIENT

    Silicon Dioxide, Aluminium Chlorohydroxy Allantoinate, Aminocaproic Acid

  • INACTIVE INGREDIENT

    D-Sorbitol Solution
    Concentrated Glycerin
    Polyethylene Glycol 1500
    Carboxymethylcellulose Sodium
    Sodium Cocoyl Glutamate
    Xylitol
    Enzymatically Modified Stevia

    Sodium Chloride
    Tocopherol Acetate
    Ascorbic Acid

    l-Menthol
    Mentha Oil

    Bifidus Extract
    Green Tea Extract

    Aloe Extract

    Sage Extract

    Matricaria Extract

    Eucalyptus Extract
    Centella extract
    Water

  • PURPOSE

    For dental care

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Apply an appropriate amount to your toothbrush and brush your teeth by brushing.

  • WARNINGS

    Warnings

    Keep out of reach of children

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

    Other Information

    ■ Store in an airtight container at room temperature

    ■ Date of use : 36 months from the date of manufacture

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    GREENSALTRAIN TOOTH 
    precipitated calcium carbonate, dibasic calcium phosphate, aminocaproic acid, aluminium chlorohydroxy allantoinate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74724-0030
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCLOXA (UNII: 18B8O9DQA2) (ALCLOXA - UNII:18B8O9DQA2) ALCLOXA0.05 g  in 100 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE13.5 g  in 100 g
    AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) AMINOCAPROIC ACID0.05 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74724-0030-1180 g in 1 TUBE; Type 0: Not a Combination Product11/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/30/2021
    Labeler - K.Boeun Pharmaceutical Co.,Ltd. (695674074)
    Registrant - K.Boeun Pharmaceutical Co.,Ltd. (695674074)
    Establishment
    NameAddressID/FEIBusiness Operations
    K.Boeun Pharmaceutical Co.,Ltd.695674074manufacture(74724-0030)