Opal™ By Opalescence ®

Opal™ By Opalescence ®
SPL v5
SPL
SPL Set ID 5c3bf8fc-2e8f-4a58-bcbf-e47540072a49
Route
DENTAL
Published
Effective Date 2023-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.1 mg)
Inactive Ingredients
Glycerin Water Silicon Dioxide Sorbitol Xylitol Methyl Salicylate Poloxamer 407 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 2029-02-21
Description

Drug Facts

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Drug Facts

Uses

Aids in the prevention of dental decay.

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.

Directions
  • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 2 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
Active Ingredients

Sodium Fluoride 0.25% w/w

Inactive Ingredients

Glycerin, Water (Aqua), Silica, Sorbitol, Xylitol, Methyl Salicylate (flavor), Poloxamer 407, 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

ORIGINAL

COOL MINT

FLUORIDE TOOTHPASTE

NET WT. 4.7 OZ

Structured Label Content

Uses

Aids in the prevention of dental decay.

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

Anticavity

Directions
  • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 2 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
Active Ingredients

Sodium Fluoride 0.25% w/w

Inactive Ingredients

Glycerin, Water (Aqua), Silica, Sorbitol, Xylitol, Methyl Salicylate (flavor), Poloxamer 407, 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

ORIGINAL

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: 2026-02-15T12:06:19.712879 · Updated: 2026-03-14T23:09:03.764166