Label: JASON TOTAL PROTECTION SENSITIVE- 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 April 12, 2021

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  • ACTIVE INGREDIENT

    Potassium Nitrate 5%

  • PURPOSE

    Tooth desensitizer

  • WARNINGS

    Sensitive teeth may indicate a seriuos problem that may need prompt care by a dentist. See your dentist if the problem persists or warsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional assistance immediately.

  • INDICATIONS & USAGE

    Tooth desensitizer

  • INACTIVE INGREDIENT

    Calcium Carbonate, Glycerin, Water (Aqua), Xylitol, Hydrated Silica, Sodium Cocoyl Glutamate, Flavor, Eugenia Caryophyllus (Clove) Flower Oil, Mentha Piperita (Peppermint) Oil, Curcuma Longa (Turmeric) Root Extract (1), Etlingera Elatior Flower Extract, Cellulose Gum, Sodium Bicarbonate, Sodium Magnesium Silicate, Sodium Sulfate.

    (1) Certified Organic Ingredient

  • DOSAGE & ADMINISTRATION

    Potassium Nitrate 5%.

    Directions: Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or doctor.

  • PRINCIPAL DISPLAY PANEL

    PDP JPG

  • INGREDIENTS AND APPEARANCE
    JASON TOTAL PROTECTION SENSITIVE 
    potassium nitrate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-1562
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    CURCUMA LONGA WHOLE (UNII: W5488JUO8U)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    ETLINGERA ELATIOR WHOLE (UNII: KF7S33DH97)  
    CLOVE OIL (UNII: 578389D6D0)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-1562-41 in 1 BOX07/01/2019
    1113 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 finalpart35607/01/2019
    Labeler - The Hain Celestial Group, Inc (117115556)
    Registrant - The Hain Celestial Group, Inc. (081512382)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc081512382manufacture(61995-1562)
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