The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity Toothpaste

The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity Toothpaste
SPL v1
SPL
SPL Set ID 426b8efa-e691-a67d-e063-6394a90abf8d
Route
TOPICAL
Published
Effective Date 2025-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.243 g)
Inactive Ingredients
1,2-hexanediol Water Sucralose Lauryl Glucoside Titanium Dioxide Caprylyl Glycol Sorbitol Hydrated Silica Sodium Lauroyl Sarcosinate Tetrapotassium Pyrophosphate Xylitol Zinc Lactate Methyl Diisopropyl Propionamide Glycerin Red 33 Sodium Gluconate Carboxymethylcellulose Sodium, Unspecified Form Sodium Phosphate, Monobasic

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-31
Description

Sodium Fluoride 0.243% (0.14% w/v fluoride ion)

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.243% (0.14% w/v fluoride ion)

Uses

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 0.243%

(0.14% w/v fluoride ion)

Inactive Ingredients

Water

Glycerin

Hydrated Silica

Xylitol

Sorbitol

Flavor

Cellulose Gum

1,2-Hexanediol

Sodium Phosphate

Sodium Lauroyl Sarcosinate

Sucralose

Tetrapotassium Pyrophosphate

Caprylyl Glycol

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

Titanium Dioxide

Red 33

When Using This Product
  • Do not swallow
  • Do not use in eye area
Keep Out of Reach of Children Under 6 Years

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

Structured Label Content

Uses

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 0.243%

(0.14% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

Water

Glycerin

Hydrated Silica

Xylitol

Sorbitol

Flavor

Cellulose Gum

1,2-Hexanediol

Sodium Phosphate

Sodium Lauroyl Sarcosinate

Sucralose

Tetrapotassium Pyrophosphate

Caprylyl Glycol

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

Titanium Dioxide

Red 33

When Using This Product (When using this product)
  • Do not swallow
  • Do not use in eye area
Keep Out of Reach of Children Under 6 Years (Keep out of reach of children under 6 years)

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:51.804163 · Updated: 2026-03-14T23:13:18.140905