Made By Dentists Ultra Whitening Professional

Made By Dentists Ultra Whitening Professional
SPL v3
SPL
SPL Set ID 177b26c8-6ad2-2e78-e063-6394a90afe6b
Route
DENTAL
Published
Effective Date 2025-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.5 mg)
Inactive Ingredients
Water Sorbitol Hydrated Silica Xylitol Cocamidopropyl Betaine Carboxymethylcellulose Sodium, Unspecified Sodium Tripolyphosphate Anhydrous Titanium Dioxide Potassium Sorbate Hydrogen Peroxide Sodium Bicarbonate Saccharin Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-01
Description

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity 

Medication Information

Purpose

Anticavity 

Description

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Use:

Aids in the prevention of cavities.

Label

Drug Facts

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), and only use a pea size amount.
  • Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.
Active Ingredient:

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Label: 62776 005 02

Inactive Ingredients:

Water (Aqua), Sorbitol, Hydrated Silica, Xylitol, Flavor, Cocamidopropyl Betaine, Cellulose Gum, Pentasodium Triphosphate, Titanium Dioxide, Sordium Saccharin, Potassium Sorbate, Hydrogen Peroxide, Sodium Bicarbonate

Questions Or Comments?

+ 1 (646) 980-6461

Keep Out of Reach of Children Under 6 Years of Age.

If more than used for brushing is accidentlly swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Use:

Aids in the prevention of cavities.

Label

Purpose

Anticavity 

Drug Facts

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), and only use a pea size amount.
  • Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.
Active Ingredient: (Active ingredient:)

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Label: 62776 005 02 (Label: 62776-005-02)

Inactive Ingredients: (Inactive ingredients:)

Water (Aqua), Sorbitol, Hydrated Silica, Xylitol, Flavor, Cocamidopropyl Betaine, Cellulose Gum, Pentasodium Triphosphate, Titanium Dioxide, Sordium Saccharin, Potassium Sorbate, Hydrogen Peroxide, Sodium Bicarbonate

Questions Or Comments? (Questions or comments?)

+ 1 (646) 980-6461

Keep Out of Reach of Children Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

If more than used for brushing is accidentlly swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:22.776750 · Updated: 2026-03-14T23:09:06.809873