Label: 28TAK DOUX TOOTH- silicon dioxide paste, dentifrice

  • NDC Code(s): 72440-010-01, 72440-010-02
  • Packager: ELMEDITEC 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 July 17, 2018

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  • ACTIVE INGREDIENT

    Active ingredients: SILICON DIOXIDE 8.0%

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  • INACTIVE INGREDIENT

    Inactive ingredients:

    D-Sorbitol Solution, Water, Concentrated Glycerin, Xantangum, Sodium Cocoyl Glutamate, Raspberry Flavor, Black Current Flavor, Xylitol, Chitosan, Rosemary Extract, Matricaria Extract, Eucalyptus Extract, Sage Extract, Aloe Extract, Green Tea Extract, Ascorbic Acid, Tocopherol Acetate

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  • PURPOSE

    Purpose: Anticavity

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  • WARNINGS

    Warnings:

    (1) Do not swallow and rinse mouth thoroughly after use (2) If you experience any problems with your gums or mouth during use, discontinue use and consult your doctor. (3) For children under 6 years of age, use small amounts of toothpaste. And use it under the supervision of a guardian to avoid sucking or swallowing. (4) Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities. (5) Keep out of the reach of children under 6 years of age.

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • Uses

    Uses:

    Keep your teeth white and strong. Keep your mouth clean. Refresh the inside of the mouth. To prevent tooth decay and remove bad breath. Increase esthetic effect. Removal of plaque (anti-plaque)

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  • Directions

    Directions:

    Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician

    Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

    Children under 2 years: Ask a dentist or physician

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    28TAK DOUX TOOTH 
    silicon dioxide paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:72440-010
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 4.8 g  in 60 g
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Xylitol (UNII: VCQ006KQ1E)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:72440-010-02 1 in 1 CARTON 07/01/2018
    1 NDC:72440-010-01 60 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 07/01/2018
    Labeler - ELMEDITEC CO.,LTD (694771074)
    Registrant - ELMEDITEC CO.,LTD (694771074)
    Establishment
    Name Address ID/FEI Business Operations
    ELMEDITEC CO.,LTD 694771074 manufacture(72440-010)
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