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

JASON POWERSMILE ANTICAVITY WHITENING PEPPERMINT (SODIUM MONOFLUOROPHOSPHATE) GEL [THE HAIN CELESTIAL GROUP, INC.]
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NDC 61995-0540-6
Set ID 663b00d2-2a68-02a8-e053-2a91aa0a2c73
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



    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 drushing. 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 physician). Children under 6: Should use only a pea sized amount of paste and be supervised as necessary. Children under 2, check with a dentist or physician before using.

  • INACTIVE INGREDIENT

    Glycerin, Aqua (Water), Silica, Sodium Cocoyl Glutamate, Xylitol, Mentha Piperita (Peppermint) Oil, Aloe Barbadensis Leaf Juice (1), Bambusa Arundinacea Stem Powder, 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, Sodium Sulfatre, Ubiquinone (2).

    (1) Certified Organic Ingredients

    (2) Coenzyme Q10

  • PRINCIPAL DISPLAY PANEL

    tube labelcarton label

  • INGREDIENTS AND APPEARANCE
    JASON POWERSMILE ANTICAVITY WHITENING PEPPERMINT 
    sodium monofluorophosphate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0540
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BAMBUSA ARUNDINACEA STEM (UNII: NRA4497HC5)  
    CITRUS MAXIMA SEED (UNII: 083X55C543)  
    PERILLA FRUTESCENS SEED (UNII: 8M62PUD356)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    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)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-0540-61 in 1 CARTON10/04/2017
    1170 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/04/2017
    Labeler - The Hain Celestial Group, Inc. (117115556)
    Registrant - The Hain Celestial Group, Inc. (081512382)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.081512382manufacture(61995-0540)

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