KIDS KARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [DEN-MAT HOLDINGS, LLC.]

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KIDS KARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [DEN-MAT HOLDINGS, LLC.]
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NDC 59883-718-04
Set ID 66d6b20f-d0ff-4dfe-e053-2991aa0a99ca
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

    Sodium Fluoride 0.24% (0.14% w/v fluoride ion)

  • Purpose

    Anticavity toothpaste

  • Uses

    Aids in the prevention of dental cavities.

  • Warnings

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 2 years of age or older: Brush teeth thoroughly, preferably after each meal or at least twice a day or as directed by a dentist or doctor.
    • Children under 2 years of age: Consult a dentist or doctor.
    • Do not swallow.
    • To minimize swallowing, use a pea-sized amount in children under 6.
    • Instruct children under 6 years of age in good brushing and rinsing habits.
    • Supervise children as necessary until capable of using without supervision.
  • Other information

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

  • Inactive ingredients

    Sorbitol, Water, Hydrated Silica, PEG-32, Cellulose Gum, Sodium Lauryl Sulfate, PEG-6, Flavor, Sodium Saccharin, Methylparaben, Propylparaben, Blue 1

  • Questions or comments?

    Call 1-800-752-2564

  • Principal Display Panel

    kids kare™

    Preventative

    Treatment

    0.24% Sodium Fluoride

    Toothpaste

    Berry Flavor

    IMPORTANT:

    Read directions carefully

    Net Wt. 4 oz. (113.4 g)

    Kids_Kare_Toothpaste

  • INGREDIENTS AND APPEARANCE
    KIDS KARE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59883-718
    Route of AdministrationDENTAL, ORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    BERRY (UNII: FV3431923Z)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59883-718-04113.4 g in 1 TUBE; Type 0: Not a Combination Product10/26/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/26/2017
    Labeler - DEN-MAT HOLDINGS, LLC. (809857704)
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