opalescence™ whitening toothpaste original cool mint

opalescence™ whitening toothpaste original cool mint
SPL v1
SPL
SPL Set ID 44e7d0ed-3c37-5889-e063-6294a90afcca
Route
dental
Published
Effective Date 2025-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.1 mg)
Inactive Ingredients
sodium lauryl sulfate fd&c yellow no. 5 sodium hydroxide aqua sorbitol silicon dioxide poloxamer 407 carbomer fd&c blue no. 1 sodium benzoate xylitol sucralose xanthan gum methyl salicylate glycerin

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
otc monograph drug active Since 2025-09-23
Purpose

Anticavity

Description

Drug Facts

Medication Information

Warnings

Warnings

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

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 0.24% w/w

Questions Or Comments

Call toll-free 1.800.552.5512

Principal Display Panel 4.7 Oz Tube Carton

Opalescence Whitening Toothpaste

Original

Cool Mint

Fluoride Toothpaste

NET WT. 4.7 oz

Structured Label Content

Warnings

Warnings

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

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 0.24% w/w

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

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: 2026-02-15T12:07:33.345997 · Updated: 2026-03-14T23:11:08.891584