Label: SPRINJENE NATURAL SENSITIVITY AND GUM- potassium nitrate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 12, 2021

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    POTASSIUM NITRATE 5%

  • PURPOSE

    ANTIHYPERSENSITIVITY

  • USE

    HELPS REDUCE TOOTH AND GUM SENSITIVITY, HELPS REMOVE SURFACE STAINS WITH REGULAR BRUSHING, AND HELPS PREVENT PLAQUE BUILDUP

  • 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. INSTRUCT CHILDREN 2 TO 6 YEARS 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 (AQUA), HYDRATED SILICA, XYLITOL, GLYCERIN, 1,3 - PROPANEDIOL (ZEMEA - MADE FROM NON-GMO CORN), NATURAL PEPPERMINT OIL, ZINC CITRATE, XANTHAN GUM, SODIUM LAURYL SULFOACETATE (LAL), NIGELLA SATIVA (BLACK SEED OIL), ZINC OXIDE, STEVIA REBAUDIANA EXTRACT, TIO2, ACACIA GUM, PUNICA GRANATUM SEED OIL (POMEGRANATE), THYMUS VULGARIS OIL (THYME), MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED AND DIST BY : HEALTH AND NATURAL
    BEAUTY USA CORP PISCATAWAY, NJ 08854

  • PRINCIPAL DISPLAY PANEL - 142 GM Tube Carton

    SprinJene
    Natural®

    SENSITIVITY & GUM

    FLUORIDE FREE

    TOOTHPASTE

    BURSTING WITH THE UNIQUE BENEFITS OF
    BLACK SEED OIL AND ZINC

    • WHITENING
    • FRESHENS BREATH
    • HELPS DRY MOUTH
    • SLS FREE
    • PRESERVATIVE FREE
    • DYE FREE
    • NATURAL PEPPERMINT OIL

    USDA
    CERTIFIED
    BIOBASED
    PRODUCT
    PRODUCT 100%

    CERTIFIED VEGAN
    VEGAN.ORG

    GLUTEN-FREE
    CERTIFIED

    NET WT 5OZ (142GM)

    PRINCIPAL DISPLAY PANEL - 142 GM Tube Carton
  • INGREDIENTS AND APPEARANCE
    SPRINJENE NATURAL   SENSITIVITY AND GUM
    potassium nitrate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63404-1984
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Potassium Nitrate (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) Potassium Nitrate50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Glycerin (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Zinc Citrate (UNII: K72I3DEX9B)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
    NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
    Zinc Oxide (UNII: SOI2LOH54Z)  
    STEVIA SERRATA FLOWER OIL (UNII: 93Z447IP63)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Acacia (UNII: 5C5403N26O)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    THYME OIL (UNII: 2UK410MY6B)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorPEPPERMINT (Minty) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63404-1984-11 in 1 CARTON02/20/2021
    1142 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35602/20/2021
    Labeler - Health and Natural Beauty USA Corp (079129688)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health and Natural Beauty USA Corp079129688MANUFACTURE(63404-1984)
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