Label: SPRINJENE NATURAL BUBBLE GUM- sodium fluoride paste, dentifrice

  • NDC Code(s): 63404-0229-1
  • Packager: Health and Natural Beauty USA Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 7, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Sodium Fluoride 0.243 % (0.14 W/V Fluoride Ion)

  • Purpose

    Anticavity

  • Use

    Helps in the prevention of cavities.

  • Warnings

    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

    Supervise children as necessary until capable of using without supervision.

    Adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day as directed by a dentist or physician. Children 2 to 6 years instruct in good brushing and rinsing habits (to minimize swallowing). Children under 2 years do not use unless directed by a dentist or physician.

  • Inactive Ingredients

    Water (Deionized), Xylitol, Sorbitol, Hydrated Silica, Glycerin, Corn Zemea (1,3-Propanediol), Xanthan, Zinc Citrate, Sodium Lauryl Sulfoacetate, Flavor, Acacia Gum, Mica, potassium sorbate, Nigella Sativa Extract (Black seed Oil), Thyme (Thymus Vulgaris), Zingiber officinale (Ginger Oil), Punica granatum Seed Oil (Pomegranate), Commiphora myrrha (Myhrr oil), Rosemary (Rosmarinus Officinalis)

  • Questions or comments?

    Call 1-844-346-2872

    www.sprinjene.com

  • SPL UNCLASSIFIED SECTION

    Manufactured and Dist. by: Health and Natural Beauty USA Corp,
    Piscataway, NJ 08854

  • PRINCIPAL DISPLAY PANEL - 100 g Tube Carton

    SprinJene
    Natural®

    CAVITY PROTECTION

    CHILDREN'S
    TOOTHPASTE

    with Black Seed Oil & Zinc

    BUBBLE GUM

    CAVITY
    PROTECTION

    FRESHENS
    BREATH

    HELPS
    DRY MOUTH

    NET WT 3.4 OZ (100g)

    PRINCIPAL DISPLAY PANEL - 100 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SPRINJENE   NATURAL BUBBLE GUM
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63404-0229
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Xylitol (UNII: VCQ006KQ1E)  
    Sorbitol (UNII: 506T60A25R)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Glycerin (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Zinc Citrate (UNII: K72I3DEX9B)  
    Sodium Lauryl Sulfoacetate (UNII: D0Y70F2B9J)  
    ACACIA (UNII: 5C5403N26O)  
    Mica (UNII: V8A1AW0880)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
    Thyme (UNII: CW657OBU4N)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    MYRRH OIL (UNII: H74221J5J4)  
    ROSEMARY (UNII: IJ67X351P9)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUM (BUBBLE GUM) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63404-0229-11 in 1 CARTON04/01/2024
    1100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02104/01/2024
    Labeler - Health and Natural Beauty USA Corp (079129688)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health and Natural Beuaty USA Corp079129688MANUFACTURE(63404-0229)
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