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%
    (1010 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 extract, hydroxyapatite, Lingusticum wallichii, mugwort extract, water

  • Questions or Comments?

    call +82(53)584 3320

  •  

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    DENTREE 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76170-101
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.22 g  in 1000 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)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorVANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76170-101-5050 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35504/01/2012
    Labeler - E-SOUP Co., Ltd. (557805059)
    Establishment
    NameAddressID/FEIBusiness Operations
    E-SOUP Co Ltd557805059manufacture(76170-101)
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