JASON SEA FRESH ANTICAVITY DEEP SEA SPEARMINT (SODIUM MONOFLUOROPHOSPHATE) GEL [THE HAIN CELESTIAL GROUP, INC.]

JASON SEA FRESH ANTICAVITY DEEP SEA SPEARMINT (SODIUM MONOFLUOROPHOSPHATE) GEL [THE HAIN CELESTIAL GROUP, INC.]
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NDC 61995-0530-6
Set ID 65e97f56-66bb-5263-e053-2a91aa0a4f14
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 tartarbuildup 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 Viridis (Spearmint) Leaf 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, Sodium Sulfatre, Ubiquinone (2).

    (1) Certified Organic Ingredients

    (2) Coenzyme Q10

  • PRINCIPAL DISPLAY PANEL

    carton labeltube label

  • INGREDIENTS AND APPEARANCE
    JASON SEA FRESH ANTICAVITY DEEP SEA SPEARMINT 
    sodium monofluorophosphate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0530
    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
    CHLORELLA PYRENOIDOSA (UNII: 591BV50NV8)  
    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)  
    PARSLEY (UNII: 58FMD0Q0EV)  
    PERILLA FRUTESCENS SEED (UNII: 8M62PUD356)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    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:61995-0530-61 in 1 CARTON09/29/2017
    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 finalpart35509/29/2017
    Labeler - The Hain Celestial Group, Inc. (117115556)
    Registrant - The Hain Celestial Group, Inc. (081512382)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.081512382manufacture(61995-0530)

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