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Freshmint Sensitive Toothpaste (Dabur India Limited)

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PASTE, DENTIFRICE 122 g in 1 TUBE (68747-6031-1) Label Information

Complete Freshmint Sensitive Toothpaste Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts:

    ACTIVE INGREDIENT

    Potassium Nitrate - 5 %
    Sodium Fluoride - 0.24 %

    PURPOSE

    Antihypersensitivity
    Anticavity

    USES

    • builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact
    • aids in the prevention of dental cavities

    WARNINGS

    When using this product do not use longer than 4 weeks unless recommended by a dentist or doctor.

    Stop and ask a dentist if problem persists or worsens. Sensitive teeth may indicate a serious problem that may require prompt care by a dentist. Keep out of reach of children.

    If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

    DIRECTIONS

    Adults and children 12 years and older

    Brush teeth for at least one minute, preferably after each meal, or at least twice a day, or as directed by your dentist. Be sure to brush sensitive areas

    Children under 12 years of age

    Consult a dentist or doctor.

    Other information

    Store In a cool dry place.

    INACTIVE INGREDIENTS: Sorbitol, Silica, Treated Water, Poly Ethylene Glycol 1500, Sodium Lauryl Sulphate, Glycerin, Flavor, Sodium Carboxy Methyl Cellulose, Titanium Dioxide, Tri Sodium Ortho Phosphate, Sodium Saccharin, Sodium Benzoate, Methyl Paraben, Propyl Paraben, Color D & C Yellow # 10, FD & C Blue # 1.


  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel - NET WT. 4.3 OZ (122g)

    Freshmint Sensitive Toothpaste Tube Label
    freshmint®

    Sensitive Toothpaste                                            NET WT. 4.3 OZ (122g)

    Anti-cavity Fluoride Tootpaste for Sensitive
    *Compare to the Active Ingredients of Sensodyne® Fresh Mint

    Principal Display Panel- Tube Label - NET WT. 4.3 OZ (122g)

    Freshmint Sensitive Toothpaste Carton Label
    freshmint®

    Sensitive Toothpaste                                            NET WT. 4.3 OZ (122g)

    Anti-cavity Fluoride Tootpaste for Sensitive
    *Compare to the Active Ingredients of Sensodyne® Fresh Mint

    Principal Display Panel - Carton Label - NET WT. 4.3 OZ (122g)

  • INGREDIENTS AND APPEARANCE
    FRESHMINT SENSITIVE TOOTHPASTE 
    fluoride toothpaste paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68747-6031
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.4 mg  in 1 g
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM NITRATE 50 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color white (white) Score     
    Shape Size
    Flavor MINT (MINT) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68747-6031-1 122 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 08/25/2009
    Labeler - Dabur India Limited (650319218)
    Establishment
    Name Address ID/FEI Business Operations
    Dabur India Limited 650319218 MANUFACTURE