OPALESCENCE WHITENING- sodium fluoride gel, dentifrice 
Ultradent Products, 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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Opalescence ®
whitening toothpaste

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

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

Principal Display Panel - 133g Box
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)

Revised: 9/2018
Document Id: b3c010b4-7dcb-417b-86b5-a3e460474ce7
Set id: d07f842e-b6f1-4ae1-b576-f542ecd02dd4
Version: 3
Effective Time: 20180905
 
Ultradent Products, Inc.