Label: DENTI WHOO BLUE TABLETGARGLE- sodium fluoride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 17, 2022

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  • ACTIVE INGREDIENT

    Sodium Fluoride

  • INACTIVE INGREDIENT

    Sodium Bicarbonate
    Tartaric Acid
    Hydroxypropylcellulose
    Hydroxypropyl methylcellulose
    Silica
    Zea Mays (Corn) Starch
    Sodium Cocoyl Glutamate
    Maltitol
    Mannitol
    Erythritol
    Potassium Acesulfame
    Magnessium Stearate
    Brilliant Blue
    Menthol
    Yucca Vera Leaf/Root Extract

    fragrance

  • PURPOSE

    Tooth-decay prevention, Odor removal from the mouth and Oral Cleansing

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    USAGE : Put 1 tablet in the mouth and use the tongue and lips to rub the gums, teeth, and tongue, gargle it with water, and rinse it several times

  • WARNINGS

    1) Observe the specified usage capacity.
    2) Store in a cool place with no sunlight and less moisture.
    3) Avoid swallowing.
    4) This product contains 583 ppm of fluorine.
    5) This product contains fluorine, so if you swallow a large amount, consult a doctor or dentist
    immediately.
    6) When used by children under the age of 6, use under the supervision of their guardians to
    avoid swallowing.
    7) Keep out of reach of children under the age of 6

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DENTI WHOO BLUE TABLETGARGLE 
    sodium fluoride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86157-0014
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.10037 g
    Inactive Ingredients
    Ingredient NameStrength
    TARTARIC ACID (UNII: W4888I119H)  
    MALTITOL (UNII: D65DG142WK)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize15mm
    FlavorMENTHOLImprint Code none
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86157-0014-18 in 1 PACKAGE; Type 0: Not a Combination Product04/06/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/06/2022
    Labeler - SUN LIFE SCIENCE CO LTD (695149648)
    Registrant - SUN LIFE SCIENCE CO LTD (695149648)
    Establishment
    NameAddressID/FEIBusiness Operations
    SUN LIFE SCIENCE CO LTD695149648manufacture(86157-0014)
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