OPALESCENCE WHITENING SENSITIVITY RELIEF- potassium nitrate and sodium fluoride gel, dentifrice

Opalescence Whitening Sensitivity Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Potassium Nitrate 5% w/w

Sodium Fluoride 0.24% w/w

Purpose

Antihypersensitivity

Anticavity

Uses

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

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 yeasrs 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

Aqua (Water), Silica, Xylitol, Glycerin, Sorbitol, Poloxamer 407, Methyl Salicylate, Sodium Lauryl Sulfate, Carbomer, FD&C Blue No. 1 (CI 42090), FD&C Yellow No. 5 (CI 19140), Flavor (Aroma), Sodium Benzoate, Sodium Hydroxide, Sucralose, Xantham Gum

Questions or comments

Call toll-free 1.800.552.5512

Principal Display Panel - 4.7 oz Tube Carton

Opalescence Whitening Toothpaste

Sensitivity Relief

Cool Mint

NET WT. 4.7 oz * 133 g 8 100 ml

FLUORIDE TOOTHPASTE

FOR SENSITIVE TEETH

INGREDIENTS AND APPEARANCE

OPALESCENCE WHITENING SENSITIVITY RELIEF 
potassium nitrate and sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51206-315
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCRALOSE (UNII: 96K6UQ3ZD4)
CARBOMER (UNII: 0A5MM307FC)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLOXAMER 407 (UNII: TUF2IVW3M2)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SORBITOL (UNII: 506T60A25R)
METHYL SALICYLATE (UNII: LAV5U5022Y)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
AQUA (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	green	Score
Shape		Size
Flavor	MINT (Cool Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51206-315-01	1 in 1 CARTON	10/08/2025
1		133 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 51206-315-02	12 in 1 PACKAGE, COMBINATION	10/08/2025
2		1 in 1 CARTON
2		133 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 51206-315-03	1 in 1 CARTON	10/08/2025
3		28 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 51206-315-04	24 in 1 PACKAGE, COMBINATION	10/08/2025
4		1 in 1 CARTON
4		28 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 51206-315-05	48 in 1 PACKAGE, COMBINATION	10/08/2025
5		1 in 1 CARTON
5		28 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	10/08/2025

Labeler - Ultradent Products, Inc. (013369913)

Establishment
Name	Address	ID/FEI	Business Operations
Ultradent Products, Inc		013369913	label(51206-315) , analysis(51206-315) , manufacture(51206-315) , pack(51206-315)