Label: DENTREE- sodium fluoride gel, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 20, 2020

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  • Active Ingredient

    Sodium fluoride-------------------0.22%
    (1000 ppm of fluoride ion)

  • Purpose

    Anticavity

  • Use

    aids in the prevention of dental cavities, reducing halitosis, and tooth whitening

  • Warnings

    keep out of reach of children.
    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 6 years of age and older

    Brushless: shake the container before pumping 2-3 times on a toothbrush to brush the teeth or into mouth for close-mouthed; gurgle the foam inside the mouth for about 30 seconds. Rinse off the residue with clean water several times to achieve the intended cleanliness.

    With Brush: after gurgle the foam inside the mouth for about 30 seconds, you may use toothbrush to clean before rinse.

    Children under 6 years old
    ask a dentist or physician

  • Other Information

    store at room temperature.

  • Inactive Ingredients

    Allantoin, Ginger, Tribasic Calcium Phosphate, Lingusticum Wallichii Whole, Artemisia princeps leaf, water

  • Questions or Comments?

    call +82(53)584 3320

  •  

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAYL PANELE-SOUP



    NDC 76170-103-02



    Dentree

    Green Foaming Toothpaste



    • Cavity Prevention



    • Halitosis Reduction



    • Tooth Whitening



    50ml



    Lot No. / Expiration Date



    E-SOUP Co., Ltd. Rm 333 R&D Center,

    Daegu Techno Park venture Factory, 62

    Seongseo Gongdan-ro 11-gil, Dalseo-gu,

    Daegu, KOREA 704-948



    Made in Korea

    Label

  • INGREDIENTS AND APPEARANCE
    DENTREE 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76170-103
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.22 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    GINGER (UNII: C5529G5JPQ)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    LIGUSTICUM WALLICHII WHOLE (UNII: 8Y1N3NX2DW)  
    ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76170-103-011 in 1 CARTON12/01/2012
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:76170-103-021 in 1 CARTON12/01/2012
    250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    3NDC:76170-103-031 in 1 CARTON12/01/2012
    3100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/01/2012
    Labeler - E-SOUP Co., Ltd. (557805059)
    Establishment
    NameAddressID/FEIBusiness Operations
    E-SOUP Co., Ltd557805059manufacture(76170-103)
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