Opal™ By Opalescence ®

Opal™ By Opalescence ®
SPL v5
SPL
SPL Set ID 5ffc0d14-0290-47bb-90e5-90a25a5acc28
Route
DENTAL
Published
Effective Date 2023-11-15
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 Xylitol Water Glycerin Sorbitol Poloxamer 407 Methyl Salicylate Sodium Lauryl Sulfate Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Fd&c Blue No. 1 Fd&c Yellow No. 5 Sodium Benzoate Sodium Hydroxide Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-11-19 Until 2029-10-15
Description

Drug Facts

Medication Information

Description

Drug Facts

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

Section 55105-1
Active Ingredients Purpose
Potassium Nitrate 5% w/w Antihypersensitivity
Sodium Fluoride 0.25% w/w 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 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

Structured Label Content

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

Section 55105-1 (55105-1)
Active Ingredients Purpose
Potassium Nitrate 5% w/w Antihypersensitivity
Sodium Fluoride 0.25% w/w 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 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 (Questions or comments)

Call toll-free 1.800.496.8330

Principal Display Panel 4.7 Oz Tube Carton (PRINCIPAL DISPLAY PANEL - 4.7 OZ Tube Carton)

opal™

by Opalescence ®

Whitening

Toothpaste

SENSITIVITY

RELIEF

COOL MINT

FLUORIDE TOOTHPASTE

NET WT. 4.7 OZ

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:19.715674 · Updated: 2026-03-14T23:09:03.764166