Label: DR. JEN SUPERPASTE NANO-HYDROXYAPATITE- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 21, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    DRUG FACTS

    Active Ingredient
    Sodium Fluoride 0.22%

  • PURPOSE

    Purpose:
    Sodium Fluoride - Anticavity

  • INDICATIONS & USAGE

    Use: Aids in the prevention of dental cavities

  • WARNINGS

    Warnings:

    If more than used for brushing is
    accidentally swallowed, get
    medical help or contact a Poison
    Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children
    under 6 years of age.

  • DOSAGE & ADMINISTRATION

    Directions: Adults and children
    2 years of age and older: Brush
    teeth thoroughly, preferably after
    each meal or at least twice a day,
    or as directed by a dentist or
    doctor. Instruct children under 6
    years of age in good brushing and
    rinsing habits (to minimize
    swallowing). Supervise children as
    necessary until capable of using
    without supervision. Children under
    2 years of age: Consult a dentist or
    doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients:Water,
    Glycerin, Hydrated Silica, Xylitol,
    Nano-Hydroxyapatite, Calcium
    Carbonate, Sodium Methyl Cocoyl
    Taurate, Sodium Carboxymethyl -
    cellulose, Natural Flavor, Menthol,
    Stevia Rebaudiana Leaf Extract,
    Citric Acid, Illicium Verum (Anise)
    Fruit Extract, Carica Papaya Extract,
    Prunus Serotina (Black Cherry) Bark
    Extract, Glycyrrhiza Uralensis
    (Chinese Licorice) Root Extract,
    Mentha Spicata (Spearmint), Mentha
    Arvensis (Peppermint), Spirulina
    Platensis Powder

  • Dr. Jen SuperPaste Product Package Labeling

    Dr. Jen

    Super Paste

    TRIPLE CAVITY
    PROTECTION

    10% NANO-HYDROXYAPATITE,
    FLUORIDE & XYLITOL
    TOOTHPASTE

    3.4 FL. OZ. | 100 ML

    DrJenNatural.com

    Dr. Jen
    St. Paul, MN 55118

    357 Box

    357 Tube

    res

  • INGREDIENTS AND APPEARANCE
    DR. JEN SUPERPASTE NANO-HYDROXYAPATITE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84181-357
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.22 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XYLITOL (UNII: VCQ006KQ1E)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    MENTHOL (UNII: L7T10EIP3A)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    STAR ANISE FRUIT (UNII: CK15HA8438)  
    CARICA PAPAYA LEAF (UNII: 66J7636Z2I)  
    GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)  
    PRUNUS SEROTINA BARK (UNII: 5D48E975HA)  
    SPEARMINT (UNII: J7I2T6IV1N)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    ARTHROSPIRA PLATENSIS (UNII: 9L3TIH1UUE)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84181-357-051 in 1 BOX03/13/2024
    1100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02103/13/2024
    Labeler - Dr Jen Natural, LLC (042902683)
    Registrant - Dr Jen Natural, LLC (042902683)