OPALESCENCE PLUS- sodium fluoride paste, 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/Purpose

Sodium Fluoride 0. 25%w/w (Anticavity)

Uses

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 over 6 years of age: Brush as directed by a dentist or physician.
  • Children of 6 years and younger: Use a pea-sized amount for supervised brushing to minimize swallowing until capable of using without supervision.
  • In case of intake of fluoride from other sources, or for children under 2 years of age, consult a dentist or doctor.

Inactive Ingredients

Water (aqua), Silica, Xylitol, Glycerin, Sorbitol, Poloxamer, Sodium Lauryl Sulfate, Carbomer, Flavor (aroma), Sodium Benzoate, Sodium Hydroxide, Sodium Saccharin, Sparkle (CI 77019, CI 77891), Titanium Dioxide (CI 77891), Xanthan Gum

PRINCIPAL DISPLAY PANEL - 28.35g carton

Xylitol may reduce
the risk of tooth decay

Opalescence® +
whitening toothpaste

Spearmint with
Fluoride plus Xylitol

NET WT. 1.0 oz • 28.35g

PRINCIPAL DISPLAY PANEL - 28.35g carton
OPALESCENCE PLUS 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51206-304
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1.13 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Sorbitol (UNII: 506T60A25R)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Xylitol (UNII: VCQ006KQ1E)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Glycerin (UNII: PDC6A3C0OX)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Xanthan Gum (UNII: TTV12P4NEE)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51206-304-071 in 1 BOX11/15/201006/05/2014
128.35 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:51206-304-061 in 1 BOX11/15/201006/05/2014
2133 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/15/201006/05/2014
Labeler - Ultradent Products, Inc. (013369916)
Establishment
NameAddressID/FEIBusiness Operations
Ultradent Products, Inc.013369916MANUFACTURE(51206-304)

Revised: 5/2016
Document Id: 776c3dc1-8a4f-447f-a4c8-a8469ad68361
Set id: 7c9cf75b-11e3-430d-9664-f91667f57433
Version: 3
Effective Time: 20160524
 
Ultradent Products, Inc.