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

  • NDC Code(s): 74724-0024-1
  • 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 May 24, 2021

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

  • ACTIVE INGREDIENT

    Precipitated Calcium Carbonate, Dibasic Calcium Phosphate, Aminocaproic Acid, Aluminium Chlorohydroxy Allantoinate

  • INACTIVE INGREDIENT

    Water, D-Sorbitol Solution, Concentrated Glycerin, Silicon Dioxide, Sodium Cocoyl Glutamate, Polyethylene Glycol 1500, Xanthangum, Mentha Oil, Enzymatically Modified Stevia, Titanium Oxide, Sodium Chloride, Propolis Extract, l-Menthol, Xylitol, Ascorbic Acid, Green Tea Extract, Aloe Extract, Tocopherol Acetate

  • 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

    1

  • INGREDIENTS AND APPEARANCE
    CLEAN BREATH TOOTH 
    precipitated calcium carbonate, dibasic calcium phosphate, aminocaproic acid, aluminium chlorohydroxy allantoinate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74724-0024
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) (CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS - UNII:L11K75P92J) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS0.07 g  in 100 g
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE36 g  in 100 g
    ALCLOXA (UNII: 18B8O9DQA2) (ALCLOXA - UNII:18B8O9DQA2) ALCLOXA0.06 g  in 100 g
    AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) AMINOCAPROIC ACID0.06 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74724-0024-130 g in 1 TUBE; Type 0: Not a Combination Product05/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2021
    Labeler - K.Boeun Pharmaceutical Co.,Ltd. (695674074)
    Registrant - K.Boeun Pharmaceutical Co.,Ltd. (695674074)
    Establishment
    NameAddressID/FEIBusiness Operations
    K.Boeun Pharmaceutical Co.,Ltd.695674074manufacture(74724-0024)