DR. ZENNI GUM PROJECT PROPOLI TOOTH FOR GUM DISEASE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ZENITON CO.,LTD.]

DR. ZENNI GUM PROJECT PROPOLI TOOTH FOR GUM DISEASE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ZENITON CO.,LTD.]
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NDC 73029-0006-1
Set ID 86b0b182-a55e-f5c2-e053-2a91aa0a1694
Category HUMAN OTC DRUG LABEL
Packager Zeniton Co.,Ltd.
Generic Name
Product Class
Product Number
Application Number PART355
  • ACTIVE INGREDIENT

    SODIUM MONOFLUOROPHOSPHATE

  • PURPOSE

    For dental care

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    A proper amount of toothpaste is put on the toothbrush and the tooth is cleaned by brushing.

  • WARNINGS

    Storage method

    1. Keep it at room temperature in a classified container.

    2. Cover and store at room temperature.

    3. Store in a not moisture and cool place.

    4. Air may come out during use of this product, but there is no problem with its weight.

    Usage Precautions

    1. Be careful not to swallow. Rinse mouth thoroughly after use

    2. If the use of toothpaste causes abnormalities such as gums or mouth injury, discontinue use and consult a doctor or dentist.

    3. For children under 6 years of age, use a small amount of toothpaste as small as pea per use, and use under the guidance of a guardian to avoid sucking or swallowing.

    4. If a child under 6 years old swallows large amount, consult with a doctor or dentist immediately.

    5. Keep out of the reach of children under 6 years of age.

    6. The fluorine content of this toothpaste is 1,000ppm.

  • INACTIVE INGREDIENT

    Aminocaproic Acid
    Aluminium Chlorohydroxy Allantoinate
    Silicon Dioxide
    Grapefruit Seed Extract
    Eucalyptus Extract
    Green Tea Extract
    Calendula Extract
    Sage Extract
    Aloe Extract
    Chitosan
    Propolis Extract
    Concentrated Glycerin
    D-Sorbitol Solution
    Xanthangum
    Xylitol
    Sodium Chloride
    Tocopherol Acetate
    Sodium Cocoyl Glutamate
    Peppermint Oil
    Mastic Oil
    Myrrh
    Aqua

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    DR. ZENNI GUM PROJECT PROPOLI TOOTH FOR GUM DISEASE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73029-0006
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.7581 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73029-0006-1100 g in 1 TUBE; Type 0: Not a Combination Product02/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/01/2019
    Labeler - Zeniton Co.,Ltd. (688416831)
    Registrant - Zeniton Co.,Ltd. (688416831)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONG IL PHARMS CO., LTD.557810721manufacture(73029-0006)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zeniton Co.,Ltd.688416831label(73029-0006)

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