opalescence™

opalescence™
SPL v9
SPL
SPL Set ID d07f842e-b6f1-4ae1-b576-f542ecd02dd4
Route
dental
Published
Effective Date 2022-02-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.1 mg)
Inactive Ingredients
glycerin saccharin sodium fd&c blue no. 1 fd&c yellow no. 5 xanthan gum sodium lauryl sulfate water sorbitol sodium benzoate xylitol silicon dioxide methyl salicylate

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
otc monograph drug completed Since 1994-07-01 Until 2030-09-30
Purpose

Anticavity

Description

Drug Facts

Medication Information

Uses

Aids in the prevention of dental decay.

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
Inactive Ingredients

Glycerin, Water (Aqua), Silica, Sorbitol, Xylitol, 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)

Description

Drug Facts

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.

Active Ingredients

Sodium Fluoride 0.25% w/w

Questions Or Comments

Call toll-free 1.800.552.5512

Principal Display Panel 100 Ml Tube Box

Opalescence™

whitening toothpaste

NET WT. 4.7 oz • 133 g • 100 ml

FLUORIDE TOOTHPASTE

Original

Cool Mint

Structured Label Content

Uses

Aids in the prevention of dental decay.

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
Inactive Ingredients

Glycerin, Water (Aqua), Silica, Sorbitol, Xylitol, 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)

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.

Active Ingredients

Sodium Fluoride 0.25% w/w

Questions Or Comments (Questions or comments)

Call toll-free 1.800.552.5512

Principal Display Panel 100 Ml Tube Box (PRINCIPAL DISPLAY PANEL - 100 ml Tube Box)

Opalescence™

whitening toothpaste

NET WT. 4.7 oz • 133 g • 100 ml

FLUORIDE TOOTHPASTE

Original

Cool Mint

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:16.224203 · Updated: 2026-03-14T23:10:32.676275