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MEDIAN New Marine fluoride (AMOREPACIFIC)

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PASTE 1 TUBE in 1 CARTON (43419-902-23) > 90 g in 1 TUBE Label Information

Complete MEDIAN New Marine fluoride Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENTS

    SODIUM FLUORIDE 0.22 % (1000 ppm/ 0.1% w/v fluoride ion)


  • PURPOSE

    Anticavity


  • USE

    Aids in the prevention of dental cavities


  • WARNINGS

    Keep out of the reach of children under 6 years of age.

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


  • DIRECTIONS

    Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least 2 times a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.


  • INACTIVE INGREDIENTS

    WATER, SORBITOL, HYDRATED SILICA, SODIUM LAURYL SULFATE, CELLULOSE GUM, PEG–32, MENTHOL, METHYLPARABEN, ALCOHOL, SODIUM SACCHARIN, TOCOPHERYL ACETATE, CAMELLIA SINENSIS LEAF EXTRACT, LAMINARIA DIGITATA EXTRACT, FRAGRANCE, MICA, TITANIUM DIOXIDE, BLUE 1 (CI 42090)


  • PRINCIPAL DISPLAY PANEL - 90 g Tube Carton

    MEDIAN

    FRESH
    MARINE

    Coolsenseâ„¢

    MEDIAN
    New Marine fluoride toothpaste 90g

    Net Wt. 3.17 oz./90 g

    Principal Display Panel - 90 g Tube Carton

  • INGREDIENTS AND APPEARANCE
    MEDIAN NEW MARINE FLUORIDE 
    sodium fluoride paste
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-902
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.198 g  in 90 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALCOHOL (UNII: 3K9958V90M)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43419-902-23 1 in 1 CARTON
    1 90 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part355 03/05/2013
    Labeler - AMOREPACIFIC (687995683)
    Establishment
    Name Address ID/FEI Business Operations
    AMOREPACIFIC 687995683 MANUFACTURE(43419-902)