Label: TANDA PEARL PROFESSIONAL WHITENING- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 3, 2012

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  • 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

    pearl™

    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 TypeHUMAN OTC DRUGItem Code (Source)NDC:46437-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride ion - UNII:Q80VPU408O) Sodium Fluoride0.33 g  in 133 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorBLUEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46437-001-011 in 1 BOX
    1133 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35508/03/2012
    Labeler - Syneron Beauty Inc. (248047115)
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