Label: SPRINJENE NATURAL APPLE-MINT- sodium monofluorophosphate paste, dentifrice
SPRINJENE NATURAL WATERMELON- sodium monofluorophosphate paste, 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 January 17, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Sodium Monofluorophosphate: 0.76% (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

    Aqua, Xylitol, Glycerin, Silica, Calcium Carbonate, Acacia Gum, Corn Zemea (1,3-Propanediol), Vegetable Betaine (Cocamidopropyl Betaine), Flavor, Black Seed Oil (Nigella sativa), Guar Gum, Xanthan Gum, Sodium Bicarbonate, Stevia Rebaudiana Extract, Zinc Citrate, Pectin.

  • 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 - 99 g Tube Carton - Natural Apple-Mint

    with Fluoride
    TOOTHPASTE FOR CHILDREN

    ✓
    Vegan
    ✓
    Gluten Free
    ✓
    Preservative Free
    ✓
    Dye Free
    ✓
    Artificial
    Sweetener Free
    ✓
    SLS Free

    SprinJene®
    Natural

    APPLE-MINT
    uses
    Natural Flavor

    with Black Seed Oil (Nigella sativa) & Zinc
    Birch Tree Xylitol & Acacia Gum

    NET WT 3.5 OZ (99 g)

    CERTIFIED VEGAN
    VEGAN.ORG
    Vegan

    GLUTEN-FREE
    CERTIFIED
    Gluten Free

    U
    Kosher

    HALAL
    Halal

    PRINCIPAL DISPLAY PANEL - 99 g Tube Carton - Natural Apple-Mint
  • PRINCIPAL DISPLAY PANEL - 99 g Tube Carton - Natural Watermelon

    with Fluoride
    TOOTHPASTE FOR CHILDREN

    ✓
    Vegan
    ✓
    Gluten Free
    ✓
    Preservative Free
    ✓
    Dye Free
    ✓
    Artificial
    Sweetener Free
    ✓
    SLS Free

    SprinJene®
    Natural

    WATERMELON
    uses
    Natural Flavor

    with Black Seed Oil (Nigella sativa) & Zinc
    Birch Tree Xylitol & Acacia Gum

    NET WT 3.5 OZ (99 g)

    CERTIFIED VEGAN
    VEGAN.ORG
    Vegan

    GLUTEN-FREE
    CERTIFIED
    Gluten Free

    U
    Kosher

    HALAL
    Halal

    PRINCIPAL DISPLAY PANEL - 99 g Tube Carton - Natural Watermelon
  • INGREDIENTS AND APPEARANCE
    SPRINJENE   NATURAL APPLE-MINT
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63404-2014
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Xylitol (UNII: VCQ006KQ1E)  
    Glycerin (UNII: PDC6A3C0OX)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Calcium Carbonate (UNII: H0G9379FGK)  
    Acacia (UNII: 5C5403N26O)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Guar Gum (UNII: E89I1637KE)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Sodium Bicarbonate (UNII: 8MDF5V39QO)  
    Zinc Citrate (UNII: K72I3DEX9B)  
    Pectin (UNII: 89NA02M4RX)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorWATERMELONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63404-2014-11 in 1 CARTON02/01/2017
    199 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35502/01/2017
    SPRINJENE   NATURAL WATERMELON
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63404-1203
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Xylitol (UNII: VCQ006KQ1E)  
    Glycerin (UNII: PDC6A3C0OX)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Calcium Carbonate (UNII: H0G9379FGK)  
    Acacia (UNII: 5C5403N26O)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Guar Gum (UNII: E89I1637KE)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Sodium Bicarbonate (UNII: 8MDF5V39QO)  
    Zinc Citrate (UNII: K72I3DEX9B)  
    Pectin (UNII: 89NA02M4RX)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorWATERMELONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63404-1203-11 in 1 CARTON02/01/2017
    199 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35502/01/2017
    Labeler - Health and Natural Beauty USA Corp (079129688)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health and Natural Beauty USA Corp079129688MANUFACTURE(63404-2014, 63404-1203)
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