Label: JASON HEALTHY MOUTH ANTICAVITY TARTAR CONTROL TEA TREE CINNAMON- sodium monofluorophosphate gel

  • 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 April 12, 2021

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  • PURPOSE

    Anticavity

  • WARNINGS

    Avoid storing at high temperatures (greater than 100°F). Protect from freezing. If you accidentally swalow more than used for brushing, seek professional assistance or contact Poison Control immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age.If you accidentally swallow more than used for brushing, get medical help or contact Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Prevent plaque and tartar buildup with regular drushing. Adults and children 2 years of age or older should brush teeth after each meal (or at least twice a day, or as directed by a dentist or physician). Children under 6: Should use only a pea sized amount of paste and be supervised as necessary. Children under 2, check with a dentist or physician before using.

  • INACTIVE INGREDIENT

    Glycerin, Aqua (Water), Hydrated Silica, Sodium Cocoyl Glutamate, Xylitol, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, Eugenia Caryophyllus (Clove) Flower Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil (1), Melia Azadirachta Seed Oil, Aloe Barbadensis Leaf Juice (1), Bambusa Arundinacea Stem Powder, Carum Petroselinum (Parsley) Extract, Citrus Grandis (Grapefruit) Seed Extract, Perilla Ocymoides Seed Extract, Stevia Rebaudiana Leaf/Stem Extract, Ascorbic Acid, Tocopheryl Acetate, Calcium Carbonate, Cellulose Gum, Citric Acid, Menthol, Sea Salt, Sodium Bicarbonate, Sodium Magnesium Silicate, Ubiquinone, Eugenol

    (1) Certified Organic Ingredients

    (2) Coenzyme Q10

  • INDICATIONS & USAGE

    Use: Prevention of cavities

  • ACTIVE INGREDIENT

    Sodium Monofluorophosphate 0.76%

  • PRINCIPAL DISPLAY PANEL

    carton labeltube label

  • INGREDIENTS AND APPEARANCE
    JASON HEALTHY MOUTH ANTICAVITY TARTAR CONTROL TEA TREE CINNAMON 
    sodium monofluorophosphate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0525
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    CLOVE OIL (UNII: 578389D6D0)  
    AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BAMBUSA ARUNDINACEA STEM (UNII: NRA4497HC5)  
    GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
    PARSLEY (UNII: 58FMD0Q0EV)  
    PERILLA FRUTESCENS SEED (UNII: 8M62PUD356)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    SEA SALT (UNII: 87GE52P74G)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EUGENOL (UNII: 3T8H1794QW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-0525-61 in 1 CARTON09/20/2017
    1170 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35509/20/2017
    Labeler - The Hain Celestial Group, Inc. (117115556)
    Registrant - The Hain Celestial Group, Inc. (081512382)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.081512382manufacture(61995-0525)