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The Natural Dentist (Caldwell Consumer Health LLC)

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PASTE, DENTIFRICE 142 g in 1 TUBE (34362-0230-1) Label Information

Complete The Natural Dentist Information

  • Active ingredient

    Potassium nitrate 5% w/w................................................... Antihypersensitivity

    Sodium fluoride 0.24% w/w (0.15% w/v fluoride ion)...............Anticavity


  • Uses

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

  • WARNINGS

    Stop use and ask a dentist if the sensitivity persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

    Do not use if safety seal is broken.

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


  • Directions

    Adults and children 12 years of age and older: Brush teeth thoroughly after meals, at least twice a day or as directed by a dentist. Make sure to brush all sensitive areas of the teeth.

    Children under 12 years of age: Consult a dentist or physician.


  • DOSAGE & ADMINISTRATION

    Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: ask a dentist.


  • Other Information

    Store in a cool dry place. Keep tube capped when not in use.


  • Inactive ingredients

    Hydrated Silica, Glycerin, Sorbitol, Water, Xylitol, Aloe Barbadensis Leaf Juice, Cellulose Gum, Cocamidopropyl Betaine, Sodium Cocoyl Glycinate, Thaumatococcus danielli Fruit Extract, Titanium Dioxide, Xanthan Gum, Citrus grandis (Grapefruit) Seed Extract, Flavor


  • PRINCIPAL DISPLAY PANEL

    mm1.jpg

    Tube Label


  • INGREDIENTS AND APPEARANCE
    THE NATURAL DENTIST  SENSITIVITY
    fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:34362-0230
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.24 g  in 100 g
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 5.0 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    THAUMATOCOCCUS DANIELLII FRUIT (UNII: 993MIP2UR1)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor MINT (Mint) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:34362-0230-1 142 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 05/01/2011
    Labeler - Caldwell Consumer Health LLC (828558713)
    Registrant - Lornamead (126440440)
    Establishment
    Name Address ID/FEI Business Operations
    Lornamead 126440440 manufacture(34362-0230) , pack(34362-0230)