TANDA PEARL PROFESSIONAL WHITENING- sodium fluoride paste, dentifrice 
Syneron Beauty Inc.

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.

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Tanda pearl™ professional whitening toothpaste

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

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.

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
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)

Revised: 8/2012
Document Id: f6b9f960-4f72-4b38-92d1-0b5b67add8a2
Set id: aff575a3-05af-49ec-92d4-d9d366779350
Version: 1
Effective Time: 20120803
 
Syneron Beauty Inc.