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

Opalescence Sensitivity Relief Whitening by

Drug Labeling and Warnings

Opalescence Sensitivity Relief Whitening 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 Ingredients

Sodium Fluoride 0.25%w/w (Anticavity), Potassium Nitrate 5%w/w.

Uses

Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.

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. 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.

Inactive Ingredients

Water (aqua), Silica, Xylitol, Glycerin, Sorbitol, Flavor (aroma), Poloxamer 407, Sodium Lauryl Sulfate, Carbomer, FD&C Blue #1 (CI 19140), FD&C Yellow #5 (CI 42090), Sodium Benzoate, Sodium Hydroxide, Sucralose, Xanthan Gum.

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 directed by a dentist or doctor.
• Children under 12 years of age: Consult a dentist or doctor.

SPL UNCLASSIFIED SECTION

Manufactured by:
Ultradent Products, Inc.
South Jordan, UT 84095, USA

PRINCIPAL DISPLAY PANEL - 133 g Tube Carton

Opalescence ®
whitening toothpaste

Cool Mint
Sensitivity
Relief

NET WT. 4.7oz 133g
FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51206-308
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
Glycerin (UNII: PDC6A3C0OX)
Xanthan Gum (UNII: TTV12P4NEE)
Water (UNII: 059QF0KO0R)
Sorbitol (UNII: 506T60A25R)
Sodium Hydroxide (UNII: 55X04QC32I)
Xylitol (UNII: VCQ006KQ1E)
Sodium Benzoate (UNII: OJ245FE5EU)
Sucralose (UNII: 96K6UQ3ZD4)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Methyl Salicylate (UNII: LAV5U5022Y)
Sodium Lauryl Sulfate (UNII: 368GB5141J)

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: 51206-308-01	1 in 1 CARTON	11/30/2015
1		28.35 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 51206-308-05	24 in 1 PACKAGE, COMBINATION	11/30/2015
2	NDC: 51206-308-01	1 in 1 CARTON
2		28.35 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 51206-308-02	1 in 1 CARTON	11/30/2015
3		133 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 51206-308-03	3 in 1 PACKAGE, COMBINATION	11/30/2015
4	NDC: 51206-308-02	1 in 1 CARTON
4		133 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 51206-308-04	12 in 1 PACKAGE, COMBINATION	11/30/2015
5	NDC: 51206-308-02	1 in 1 CARTON
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 NOT FINAL	part356	11/30/2015

Labeler - Ultradent Products, Inc. (013369913)

Establishment
Name	Address	ID/FEI	Business Operations
Ultradent Products, Inc.		013369913	MANUFACTURE(51206-308) , ANALYSIS(51206-308) , LABEL(51206-308) , PACK(51206-308)