JASON POWERSMILE ANTICAVITY ,WHITENING POWERFUL PEPPERMINT (SODIUM MONOFLUOROPHOSPHATE ) GEL [THE HAIN CELESTIAL GROUP, INC.]

JASON POWERSMILE ANTICAVITY ,WHITENING POWERFUL PEPPERMINT (SODIUM MONOFLUOROPHOSPHATE ) GEL [THE HAIN CELESTIAL GROUP, INC.]
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NDC 61995-0101-6
Set ID 9f059808-9b23-47a6-b05b-efe7c5e13342
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 cavities
  • WARNINGS

    Avoid storing at high temperatures (greater than 100°F). Protect from freezing.

  • 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, Mentha Piperita (Peppermint) Oil, Aloe Barbadensis Leaf Juice (1),Aphanizomenon Flos-Aquae Powder, Bambusa Arundinacea Stem Powder, Carum Petroselinum (Parsley) Extract,Citrus Grandis (Grapefruit) Seed Extract, Perilla Ocymoides Seed Extract, Stevia Rebaudiana Leaf/Steam Extract, Calcium Carbonate, Cellulose Gum, Dimethyl Sulfone, 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-01weekdays from 7am-5pm MST or visit www.jason-natural.com

  • PRINCIPAL DISPLAY PANEL

                 
    image of tube label
               
    image of carton label
                    
               
                            
                
  • INGREDIENTS AND APPEARANCE
    JASON POWERSMILE ANTICAVITY ,WHITENING POWERFUL PEPPERMINT 
    sodium monofluorophosphate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0101
    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)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    APHANIZOMENON FLOS-AQUAE (UNII: 49VG1X560X)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-0101-61 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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