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Tanda pearl professional whitening (Syneron Beauty Inc.)

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Dosage Form Package Information Links
PASTE, DENTIFRICE 1 TUBE in 1 BOX (46437-001-01) > 133 g in 1 TUBE Label Information

Complete Tanda pearl professional whitening Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active Ingredients

    Sodium Fluoride 0.25% w/w


  • Purpose

    anticavity


  • Uses

    Aids in prevention of dental decay


  • Warning

    Keep out of 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 twice 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

    Glycerin, Water (Aqua), Silica, Sorbitol, Xylitol, Flavor (Aroma), Poloxamer, Sodium Lauryl Sulfate, Carbomer, FD&C Blue #1 (CI 42090), Sodium Benzoate, Sodium Hydroxide, Sparkle (CI 77019, CI 77891), Sucralose, and Xanthan Gum.


  • SPL UNCLASSIFIED SECTION

    Distributed by Syneron Beauty Inc., 11-380 Jamieson Parkway, Cambridge, ON, N3C 4N4

    Manufactured by Ultradent Products, Inc. South Jordan, Utah 84095, USA.


  • PRINCIPAL DISPLAY PANEL - 133g Tube Carton

    TANDA

    pearlâ„¢

    professional whitening
    toothpaste

    NET WT 4.7 oz 133g

    Cool mint with fluoride

    PRINCIPAL DISPLAY PANEL - 133g Tube Carton

  • INGREDIENTS AND APPEARANCE
    TANDA PEARL PROFESSIONAL WHITENING 
    sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:46437-001
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride ion - UNII:Q80VPU408O) Sodium Fluoride 0.33 g  in 133 g
    Inactive Ingredients
    Ingredient Name Strength
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Sorbitol (UNII: 506T60A25R)  
    Xylitol (UNII: VCQ006KQ1E)  
    Methyl Salicylate (UNII: LAV5U5022Y)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    FD&C Blue NO. 1 (UNII: H3R47K3TBD)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Product Characteristics
    Color BLUE Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46437-001-01 1 in 1 BOX
    1 133 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 08/03/2012
    Labeler - Syneron Beauty Inc. (248047115)