JASON NUTRISMILE ANTICAVITY ORANGE CINNAMON MINT (SODIUM MONOFLUOROPHOSPHATE ) GEL [THE HAIN CELESTIAL GROUP, INC.]

JASON NUTRISMILE ANTICAVITY ORANGE CINNAMON MINT (SODIUM MONOFLUOROPHOSPHATE ) GEL [THE HAIN CELESTIAL GROUP, INC.]
PDF | XML

NDC 61995-0102-6
Set ID 08c84332-a8af-45c4-9226-efbb3eaedea3
Category HUMAN OTC DRUG LABEL
Packager The Hain Celestial Group, Inc.
Generic Name
Product Class
Product Number
Application Number PART355
  • ACTIVE INGREDIENT


    Sodium Monofluorophosphate     0.76%



  • PURPOSE

    Anticavity

  • INDICATIONS & USAGE


    Prevention of cavites
  • WARNINGS

    Avoid storing at high temperatures (greater than 100°F). Protect from freezing. If you accidentally swallow more than used for brushing, get medical help or contact Poison Control Center immediately.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Adults and children 2 years of age or older: brush teeth throughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. Instruct children under 6 years of age in good brushing and rinsing habits (to monomize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6: Use a pea sized  amount. Children under 2: Ask a dentist or physician.

  • INACTIVE INGREDIENT

     Glycerin, Aqua (Water), Silica, Sodium Cocoyl Glutamate, Xylitol, Aloe Barbadensis Leaf Juice (1), Bambusa Arundinacea Stem Powder, Citrus Grandis (Grapefruit) Seed Extract, Daucus Carota Sativa (Carrot) Root Extract, Perilla Ocymoides Seed Extract,  Stevia Rebaudiana Leaf/Steam Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Cinnamomum Zeylancium Bark Oil, Mentha Piperita (Peppermint) Oil, Ascorbic Acid, Calcium Ascorbate, Calcium Carbonate, Cellulose Gum, Dimethyl Sulfone, Menthol, Tocopheryl Acetate, Sodium Bicarbonate, Sodium Magnesium Silicate, Ubiquinone (2)


    (1) Certified Organic Ingredients

    (2) Coenzyme Q10

  • QUESTIONS

    Questions? Call Toll Free 1-877-JASON-01or visit www.jason-natural.com

  • PRINCIPAL DISPLAY PANEL

             
    image of tube label
               
    image of carton label
                
  • INGREDIENTS AND APPEARANCE
    JASON NUTRISMILE ANTICAVITY ORANGE CINNAMON MINT 
    sodium monofluorophosphate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (MONOFLUOROPHOSPHATE ION - UNII:4964UZ79MI) SODIUM MONOFLUOROPHOSPHATE0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    CITRUS MAXIMA SEED (UNII: 083X55C543)  
    CARROT (UNII: L56Z1JK48B)  
    PERILLA FRUTESCENS SEED (UNII: 8M62PUD356)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CALCIUM ASCORBATE (UNII: 183E4W213W)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    MENTHOL (UNII: L7T10EIP3A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-0102-61 in 1 CARTON
    1170 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35509/20/2011
    Labeler - The Hain Celestial Group, Inc. (858894996)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.858894996manufacture

Related Drugs