Label: SPRINJENE HEALTH BOOST- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 63404-1108-1, 63404-1108-2
  • Packager: Health and Natural Beauty USA Corp
  • 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 February 2, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Sodium Monofluorophosphate 0.76% (0.15% 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 w ithout 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 2-6 years old 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, hydrated silica, sorbitol, glycerin, xylitol, erythritol, poloxamer 407, cocamidopropyl betaine, flavor, cellulose gum, zinc citrate, zinc oxide, sodium lauryl sulfoacetate, nigella sativa oil (black seed oil), titanium dioxide, xanthan gum

  • Questions or comments?

    Call toll free 1-844-346-2872
    www.sprinjene.com

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 142 g Tube Carton

    SprinJene®
    Fluoride Toothpaste

    NET WT 5 OZ (142g)

    Bursting with the
    unique benefits of
    Black Seed Oil

    CERTIFIED VEGAN
    VEGAN.ORG

    Health Boost Paste

    PRINCIPAL DISPLAY PANEL - 142 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SPRINJENE   HEALTH BOOST
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63404-1108
    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)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Sorbitol (UNII: 506T60A25R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Xylitol (UNII: VCQ006KQ1E)  
    Erythritol (UNII: RA96B954X6)  
    Poloxamer 407 (UNII: TUF2IVW3M2)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Carboxymethylcellulose Sodium, Unspecified (UNII: K679OBS311)  
    Zinc Citrate (UNII: K72I3DEX9B)  
    Zinc Oxide (UNII: SOI2LOH54Z)  
    Sodium Lauryl Sulfoacetate (UNII: D0Y70F2B9J)  
    Nigella Sativa Seed Oil (UNII: CS4U38E731)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINT (Minty) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63404-1108-11 in 1 CARTON07/01/2016
    1142 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:63404-1108-21 in 1 CARTON07/01/2016
    242 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35507/01/2016
    Labeler - Health and Natural Beauty USA Corp (079129688)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health and Natural Beauty USA Corp079129688MANUFACTURE(63404-1108)
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