OPAL BY OPALESCENCE SENSITIVITY- potassium nitrate and sodium fluoride gel, dentifrice 
Ultradent Products, Inc.

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Opal™ by Opalescence ®Sensitivity

Drug Facts

Active IngredientsPurpose
Potassium Nitrate 5% w/wAntihypersensitivity
Sodium Fluoride 0.25% w/wAnticavity

Uses

Warnings

Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.

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

Other Information

Inactive Ingredients

Water (Aqua), Silica, Xylitol, Glycerin, Sorbitol, Poloxamer 407, Methyl Salicylate (flavor), Sodium Lauryl Sulfate, Carbomer, Cool Mint Flavor, FD&C Blue #1 (CI 42090), FD&C Yellow #5 (CI 19140), Wintermint Flavor, Sodium Benzoate, Sodium Hydroxide, Sucralose, Xantham Gum

Questions or comments

Call toll-free 1.800.496.8330

PRINCIPAL DISPLAY PANEL - 4.7 OZ Tube Carton

opal™
by Opalescence ®

Whitening
Toothpaste

SENSITIVITY
RELIEF

COOL MINT

FLUORIDE TOOTHPASTE
NET WT. 4.7 OZ

PRINCIPAL DISPLAY PANEL - 4.7 OZ Tube Carton
OPAL BY OPALESCENCE SENSITIVITY 
potassium nitrate and sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51206-311
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
XYLITOL (UNII: VCQ006KQ1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51206-311-023 in 1 PACKAGE, COMBINATION11/19/2023
1NDC:51206-311-011 in 1 CARTON
1133 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02211/19/2023
Labeler - Ultradent Products, Inc. (013369913)
Establishment
NameAddressID/FEIBusiness Operations
Ultradent Products, Inc.013369913analysis(51206-311) , manufacture(51206-311) , label(51206-311) , pack(51206-311)

Revised: 3/2024
Document Id: 136691a0-c2fb-807e-e063-6394a90ac2f9
Set id: 5ffc0d14-0290-47bb-90e5-90a25a5acc28
Version: 3
Effective Time: 20240311
 
Ultradent Products, Inc.