OPALESCENCE WHITENING- sodium fluoride gel, dentifrice

Opalescence Whitening by

Drug Labeling and Warnings

Opalescence Whitening by is a Otc medication manufactured, distributed, or labeled by Ultradent Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium Fluoride 0.25%w/w

Purpose

Anticavity

Use

aids in the 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), FD&C Yellow#5 (CI 19140), Sodium Benzoate, Sodium Hydroxide, Sparkle (CI 77019, CI 77891), Sucralose, Xanthan Gum

SPL UNCLASSIFIED SECTION

Manufactured by Ultradent Products, Inc.
www.ultradent.com 800.552.5512
South Jordan, Utah 84095, USA
30302.11 030910

PRINCIPAL DISPLAY PANEL - 133g Box

Opalescence ®
whitening toothpaste

Cool Mint with Fluoride

NET WT. 4.7 oz 133g

INGREDIENTS AND APPEARANCE

OPALESCENCE WHITENING 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51206-302
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sorbitol (UNII: 506T60A25R)
Sodium Benzoate (UNII: OJ245FE5EU)
Xylitol (UNII: VCQ006KQ1E)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Methyl Salicylate (UNII: LAV5U5022Y)
Glycerin (UNII: PDC6A3C0OX)
Saccharin Sodium (UNII: SB8ZUX40TY)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
FD&C Yellow No. 5 (UNII: I753WB2F1M)
Xanthan Gum (UNII: TTV12P4NEE)
Sodium Lauryl Sulfate (UNII: 368GB5141J)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51206-302-07	1 in 1 BOX	07/01/1994
1		28.35 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 51206-302-10	24 in 1 PACKAGE, COMBINATION	06/01/2016
2	NDC: 51206-302-07	1 in 1 BOX
2		28.35 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 51206-302-06	1 in 1 BOX	07/01/1994
3		133 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 51206-302-08	3 in 1 PACKAGE, COMBINATION	06/01/2016
4	NDC: 51206-302-06	1 in 1 BOX
4		133 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 51206-302-09	12 in 1 PACKAGE, COMBINATION	06/01/2016
5	NDC: 51206-302-06	1 in 1 BOX
5		133 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/01/1994

Labeler - Ultradent Products, Inc. (013369913)

Establishment
Name	Address	ID/FEI	Business Operations
Ultradent Products, Inc.		013369913	MANUFACTURE(51206-302) , ANALYSIS(51206-302) , LABEL(51206-302) , PACK(51206-302)