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NDC 51206-0308-04 Opalescence Sensitivity Relief Whitening 50; 1.1 mg/g; mg/g Details

Opalescence Sensitivity Relief Whitening 50; 1.1 mg/g; mg/g

Opalescence Sensitivity Relief Whitening is a DENTAL GEL, DENTIFRICE in the HUMAN OTC DRUG category. It is labeled and distributed by Ultradent Products, Inc.. The primary component is POTASSIUM NITRATE; SODIUM FLUORIDE.

Product Information

NDC	51206-0308
Product ID	51206-308_e2ae1bba-6fcc-40cd-a0b7-482115391568
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Opalescence Sensitivity Relief Whitening
Proprietary Name Suffix	n/a
Non-Proprietary Name	Potassium Nitrate and Sodium Fluoride
Product Type	HUMAN OTC DRUG
Dosage Form	GEL, DENTIFRICE
Route	DENTAL
Active Ingredient Strength	50; 1.1
Active Ingredient Units	mg/g; mg/g
Substance Name	POTASSIUM NITRATE; SODIUM FLUORIDE
Labeler Name	Ultradent Products, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 51206-0308-04 (51206030804)

Pricing Information	N/A
NDC Package Code	51206-308-04
Billing NDC	51206030804
Package	12 CARTON in 1 PACKAGE, COMBINATION (51206-308-04) / 1 TUBE in 1 CARTON (51206-308-02) / 133 g in 1 TUBE
Marketing Start Date	2015-11-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b5176a84-76a3-4ad0-a2e2-4997a12da9a5 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

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, Flavor (Aroma), Poloxamer 407, Sodium Lauryl Sulfate, Carbomer, Sodium Benzoate, Sodium Hydroxide, Sucralose, Xanthan Gum, FD&C Blue No. 1 (CI 42090), FD&C Yellow No. 5 (CI 19140)

Questions or comments

Call toll-free 1.800.552.5512

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. 4.7 oz • 133 g • 100 ml

FLUORIDE TOOTHPASTE

FOR SENSITIVE TEETH

PRINCIPAL DISPLAY PANEL - 133 g Tube Carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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
6	NDC:51206-308-06	6 in 1 PACKAGE, COMBINATION	11/30/2015
6	NDC:51206-308-02	1 in 1 CARTON
6		133 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	11/30/2015

Labeler - Ultradent Products, Inc. (013369913)

Name	Address	ID/FEI	Business Operations
Establishment
OraTech, LLC		827869285	MANUFACTURE(51206-308) , ANALYSIS(51206-308) , LABEL(51206-308) , PACK(51206-308)

Revised: 2/2022

Document Id: e2ae1bba-6fcc-40cd-a0b7-482115391568

Set id: b5176a84-76a3-4ad0-a2e2-4997a12da9a5

Version: 7

Effective Time: 20220203

Search by Drug Name or NDC

NDC 51206-0308-04 Opalescence Sensitivity Relief Whitening 50; 1.1 mg/g; mg/g Details

Opalescence Sensitivity Relief Whitening 50; 1.1 mg/g; mg/g

Product Information

Package

Package Images

NDC 51206-0308-04 (51206030804)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b5176a84-76a3-4ad0-a2e2-4997a12da9a5 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Directions

Other Information

Inactive Ingredients

Questions or comments

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 133 g Tube Carton

INGREDIENTS AND APPEARANCE

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