Opalescence™ Whitening Toothpaste Sensitivity Relief

Opalescence™ Whitening Toothpaste Sensitivity Relief
SPL v1
SPL
SPL Set ID 44e94663-895b-67da-e063-6394a90a5fe6
Route
DENTAL
Published
Effective Date 2025-10-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (50 mg) Fluoride Ion (1.1 mg)
Inactive Ingredients
Silicon Dioxide Sucralose Carbomer Sodium Lauryl Sulfate Poloxamer 407 Fd&c Yellow No. 5 Sorbitol Methyl Salicylate Xylitol Sodium Benzoate Sodium Hydroxide Aqua Xanthan Gum Glycerin Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-08

Description

Drug Facts

Purpose

Antihypersensitivity Anticavity


Medication Information

Purpose

Antihypersensitivity

Anticavity

Description

Drug Facts

Uses
  • Aids in the prevention of dental cavities
  • Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
Section 42229-5

Drug Facts

Section 50565-1

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

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

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
Active Ingredients

Potassium Nitrate 5% w/w

Sodium Fluoride 0.24% w/w

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


Structured Label Content

Uses
  • Aids in the prevention of dental cavities
  • Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Purpose

Antihypersensitivity

Anticavity

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

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
Active Ingredients

Potassium Nitrate 5% w/w

Sodium Fluoride 0.24% w/w

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 (Questions or comments)

Call toll-free 1.800.552.5512

Principal Display Panel 4.7 Oz Tube Carton (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


Advanced Ingredient Data


Raw Label Data

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