JASON HEALTHY MOUTH ANTICAVITY ,TARTAR CONTROL TEA TREE OIL AND CINNAMON (SODIUM MONOFLUOROPHOSPHATE ) GEL [THE HAIN CELESTIAL GROUP, INC.]

JASON HEALTHY MOUTH ANTICAVITY ,TARTAR CONTROL TEA TREE OIL AND CINNAMON (SODIUM MONOFLUOROPHOSPHATE ) GEL [THE HAIN CELESTIAL GROUP, INC.]
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NDC 61995-0103-6
Set ID a92aafc4-8202-4af0-b8f2-43b8bb5cfb74
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, Carum Petroselinum (Parsley) Extract,Citrus Grandis (Grapefruit) Seed Extract, Perilla Ocymoides Seed Extract, Stevia Rebaudiana Leaf/Steam Extract, Cinnamomum Zeylancium Bark Oil, Eugenia Caryophyllus (Clove) Flower Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil (1), Melia Azadirachta Seed Oil,Calcium Carbonate, Cellulose Gum, Dimethyl Sulfone, Menthol, Sea Salt, 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 HEALTHY MOUTH ANTICAVITY ,TARTAR CONTROL TEA TREE OIL AND CINNAMON  
    sodium monofluorophosphate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0103
    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)  
    PARSLEY (UNII: 58FMD0Q0EV)  
    PERILLA FRUTESCENS SEED (UNII: 8M62PUD356)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    CLOVE OIL (UNII: 578389D6D0)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)  
    SEA SALT (UNII: 87GE52P74G)  
    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:61995-0103-61 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

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