Label: SPRINJENE WHITE BOOST- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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 9, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Sodium Fluoride 0.243% (0.15% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    Helps in the prevention of caries

  • 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 under 2 to 6 years instruct in good brushing and rinsing habbits (to minimize swallowing).

    Children under 2 years do not use unless directed by a dentist or physician.

  • Inactive Ingredients

    Water, hydrated silica, glycerin, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, zinc oxide, tetrasodium pyrophosphate, black seed oil, zinc citrate, titanium dioxide, xanthan gum, sodium saccharin

  • Questions or comments?

    Call toll free 1-844-3-462872
    www.sprinjene.com

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 142 g Tube Carton

    NEW

    SprinJene™
    Fluoride Toothpaste

    NET WT 5.0 OZ (142 g)

    Bursting with the
    unique benefits of
    Black Seed Oil

    CERTIFIED VEGAN
    VEGAN.ORG

    White Boost Paste

    PRINCIPAL DISPLAY PANEL - 142 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SPRINJENE   WHITE BOOST
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63404-1116
    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)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sorbitol (UNII: 506T60A25R)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Carboxymethylcellulose Sodium (UNII: K679OBS311)  
    Zinc Oxide (UNII: SOI2LOH54Z)  
    Guizotia Abyssinica Seed Oil (UNII: QX0GL46299)  
    Sodium Pyrophosphate (UNII: O352864B8Z)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Zinc Citrate (UNII: K72I3DEX9B)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINT (Mint/Clove) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63404-1116-11 in 1 CARTON
    1142 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:63404-1116-21 in 1 CARTON
    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 FINALpart35510/10/2014
    Labeler - Health and Natural Beauty USA Corp (079129688)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health and Natural Beauty USA Corp079129688MANUFACTURE(63404-1116)
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