The Simpsons Purple Squishee Flavor Sodium Fluoride Anticavity Toothpaste

The Simpsons Purple Squishee Flavor Sodium Fluoride Anticavity Toothpaste
SPL v1
SPL
SPL Set ID 3de10638-1a39-b747-e063-6294a90a4ca5
Route
DENTAL
Published
Effective Date 2025-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.243 g)
Inactive Ingredients
Potassium Pyrophosphate Sodium Gluconate Fd&c Blue No. 1 Cellulose Gum Water Xylitol Lauryl Glucoside Methyl Diisopropyl Propionamide Sucralose D&c Red No. 33 Xanthan Gum Sorbitol Glycerin Sodium Lauroyl Sarcosinate 1,2-hexanediol Sodium Phosphate Zinc Lactate Hydrated Silica Sodium Methyl Cocoyl Taurate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-03

Description

Sodium Fluoride 0.24% (0.14 w/v fluoride ion)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.24% (0.14 w/v fluoride ion)

Use

Aids in the prevention of dental cavities

Label

Warnings

Warnings

Directions
  • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use 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.
Active Ingredient

Sodium Fluoride 0.24%

(0.14 w/v fluoride ion)

Inactive Ingredients

Water

Sorbitol

Glycerin

Hydrated Silica

Xylitol

Sodium methyl cocoyl taurate

Flavor

Sucralose

Xanthan Gum

Sodium Lauroyl Sarcosinate

Tetrapotassium Phosphate

1,2-Hexanediol

Cellulose Gum

Sodium Phosphate

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

D&C Red No. 33

FD&C Blue No. 1

Questions Or Comments

+1-302-440-3558

You may also report serious side effects to this phone number.

When Using This Product

Do not swallow

Do not use in eye area

Keep Out of Reach of Children

Keep out of reach of children under 6 years old of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

Aids in the prevention of dental cavities

Label

Purpose

Anticavity

Warnings

Warnings

Directions
  • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use 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.
Active Ingredient (Active ingredient)

Sodium Fluoride 0.24%

(0.14 w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

Water

Sorbitol

Glycerin

Hydrated Silica

Xylitol

Sodium methyl cocoyl taurate

Flavor

Sucralose

Xanthan Gum

Sodium Lauroyl Sarcosinate

Tetrapotassium Phosphate

1,2-Hexanediol

Cellulose Gum

Sodium Phosphate

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

D&C Red No. 33

FD&C Blue No. 1

Questions Or Comments (Questions or comments)

+1-302-440-3558

You may also report serious side effects to this phone number.

When Using This Product (When using this product)

Do not swallow

Do not use in eye area

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children under 6 years old of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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