Label: JASON HEALTHY MOUTH FLUORIDE CINNAMON ANTICAVITY- sodium fluoride gel

  • NDC Code(s): 61995-0603-1
  • Packager: The Hain Celestial Group, Inc.
  • 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 June 5, 2023

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

View All Sections
  • ACTIVE INGREDIENT



    Sodium Fluoride 0.24%

  • PURPOSE

    Anticavity

  • INDICATIONS & USAGE



    use: Prevention of cavities

  • 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 brushing. 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 doctor). Children under 6: To minimize swallowing, use a pea sized amount of paste and supervise rushing until good habits are established. Children under 2, check with a dentist or physician before using.

  • INACTIVE INGREDIENT

    Glycerin, Water (Aqua), Hydrated Silica, Sodium Laurylglucosides Hydroxypropylsulfonate, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, Eugenia Caryophyllus (Clove) Flower Oil, Chondrus Crispus (Carrageenan), Stevia Rebaudiana Leaf/Stem Extract, Citric Acid, Menthol, Sodium Chloride, Titanium Dioxide, Xanthan Gum, Sodium Benzoate, Cinnamal, Eugenol

  • PRINCIPAL DISPLAY PANEL

    Cinnamon

  • INGREDIENTS AND APPEARANCE
    JASON HEALTHY MOUTH FLUORIDE CINNAMON ANTICAVITY 
    sodium fluoride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0603
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYLGLUCOSIDES HYDROXYPROPYLSULFONATE (UNII: Z6GFR7R72Y)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    MENTHOL, (+)- (UNII: C6B1OE8P3W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CLOVE OIL (UNII: 578389D6D0)  
    EUGENOL (UNII: 3T8H1794QW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-0603-11 in 1 CARTON02/01/2021
    1119 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/01/2021
    Labeler - The Hain Celestial Group, Inc. (117115556)
    Registrant - The Hain Celestial Group, Inc. (014334364)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.081512382manufacture(61995-0603)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!