KIDS KARE (STANNOUS FLUORIDE) GEL [DEN-MAT HOLDINGS, LLC.]

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KIDS KARE (STANNOUS FLUORIDE) GEL [DEN-MAT HOLDINGS, LLC.]
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NDC 59883-404-04
Set ID 66d7ae1f-ff7a-7fe4-e053-2991aa0a9f91
Category HUMAN OTC DRUG LABEL
Packager DEN-MAT HOLDINGS, LLC.
Generic Name
Product Class
Product Number
Application Number PART355
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  • Active ingredient

    Stannous Fluoride 0.4% (0.12% w/v fluoride ion)

  • Purpose

    Anticavity

  • Uses

    Aids in the prevention of dental cavities.

  • Warnings

    This is an anticavity fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.

  • WHEN USING

    When using this product it may produce surface staining of the teeth, Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

  • KEEP OUT OF REACH OF CHILDREN

    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: Use once a day after brushing your teeth with a toothpaste.
    • Apply the get to your teeth and brush thoroghly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing.
    • Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
    • Children under 6 years of age: Consult a dentist or doctor.
  • Other information

    Do not use if the foil seal under the cap is torn, cut or missing.

  • inactive ingredient

    Ascorbic Acid, Carbomer, Citric Acid, Flavor, Glycerin, Triethanolamine

  • Questions or comments?

    1-800-752-2564

  • Principal Display Panel

    kids kare™

    Preventative Treatment

    0.4% Stannous Fluoride

    Brush-On Gel

    BERRY FLAVOR

    IMPORTANT:

    Read directions carefully

    Net Wt. 4.3 oz. (121.9 g)

    Kids Kare stannous gel

  • INGREDIENTS AND APPEARANCE
    KIDS KARE 
    stannous fluoride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59883-404
    Route of AdministrationDENTAL, ORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.969 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BERRY (UNII: FV3431923Z)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59883-404-04121.9 g in 1 TUBE; Type 0: Not a Combination Product10/12/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/12/2017
    Labeler - DEN-MAT HOLDINGS, LLC. (809857704)
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