TANDA PEARL PROFESSIONAL WHITENING- sodium fluoride paste, dentifrice

Tanda pearl professional whitening by

Drug Labeling and Warnings

Tanda pearl professional whitening by is a Otc medication manufactured, distributed, or labeled by Syneron Beauty Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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)