Made By Dentists Ultra Whitening Toothpaste Fresh Mint

Made By Dentists Ultra Whitening Toothpaste Fresh Mint
SPL v2
SPL
SPL Set ID dbce2aba-48db-4e78-bf79-74f34868ee37
Route
DENTAL
Published
Effective Date 2024-03-15
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 2024-02-22

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.

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 75065 027 06

Label 75065 027 07

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.

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 75065 027 06 (Label 75065-027-06)

Label 75065 027 07 (Label 75065-027-07)

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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