Label: HYDROGEMTOOTHPASTE- calcium hydrogen phosphate hydrate paste, dentifrice

  • NDC Code(s): 83811-0001-1
  • Packager: H2 biohealthcare Co.,Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 19, 2023

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  • ACTIVE INGREDIENT

    calcium hydrogen phosphate hydrate

  • PURPOSE

    ■ Prevention of cavities, removal of bad breath, prevention of gum disease

    ■ Prevention of gingivitis and periodontitis

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    apply appropriate amount of the tooth paste on the tooth brush and brush the teeth

  • WARNINGS

    For dental use only

    When using this product

    ■ top use and ask a dentist if oral irritation or tooth sensitivity occurs

    ■ Be careful not to swallow and rinse your mouth thoroughly after use.

    ■ If any abnormality occurs while using toothpaste, such as damage to the gums or inside of the mouth, stop using it immediately and consult a dentist.

  • INACTIVE INGREDIENT

    L-menthol, glycerin, saccharin sodium hydrate, spearmint oil, xylitol, purified water, sodium carboxymethyl cellulose, cocamidopropyl betaine, propolis

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HYDROGEMTOOTHPASTE 
    calcium hydrogen phosphate hydrate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83811-0001
    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, ANHYDROUS2.14 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83811-0001-1150 g in 1 TUBE; Type 0: Not a Combination Product11/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/20/2023
    Labeler - H2 biohealthcare Co.,Ltd (695269509)
    Registrant - H2 biohealthcare Co.,Ltd (695269509)
    Establishment
    NameAddressID/FEIBusiness Operations
    H2 biohealthcare Co.,Ltd695269509manufacture(83811-0001)
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