OPAL BY OPALESCENCE SENSITIVITY- potassium nitrate and sodium fluoride gel, dentifrice

Opal by Opalescence Sensitivity by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Potassium Nitrate 5% w/w	Antihypersensitivity
Sodium Fluoride 0.25% w/w	Anticavity

Uses

• Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
• Aids in the prevention of dental cavities.

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

• Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth.
• Children under 12 years of age: Consult a dentist or doctor.

Other Information

• Do not use if tamper-evident seal is broken
• Store at room temperature
• Contains FD&C Yellow No.5 (tartrazine) as a color additive

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

INGREDIENTS AND APPEARANCE

OPAL BY OPALESCENCE SENSITIVITY 
potassium nitrate and sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51206-311
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	50 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	green	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51206-311-02	3 in 1 PACKAGE, COMBINATION	11/19/2023
1	NDC: 51206-311-01	1 in 1 CARTON
1		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 Drug	M022	11/19/2023

Labeler - Ultradent Products, Inc. (013369913)

Establishment
Name	Address	ID/FEI	Business Operations
Ultradent Products, Inc.		013369913	analysis(51206-311) , manufacture(51206-311) , label(51206-311) , pack(51206-311)