Active Ingredients And Purpose
Active ingredient
Sodium Fluoride 0.243% (0.14% w/v fluoride ion)
Purpose
Anticavity
The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity Toothpast
- Manufacturer
- HISMILE PTY LTD | Nutrix International, LLC.
- Effective date
- 2025-10-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:41:20
Key Label Information#
Uses
Uses
Aids in the prevention of dental cavities.
Warnings
Warnings
Warnings
Directions And Dosage
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.
Other Label Information
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
Label
Label Images#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 891775 | sodium fluoride 0.243 % Toothpaste | PSN | 1 |
| 891775 | sodium fluoride 0.00243 MG/MG Toothpaste | SCD | 1 |
| 891775 | sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste | SY | 1 |
| 891775 | sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste | SY | 1 |
| 891775 | sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste | SY | 1 |
| 891775 | sodium fluoride 0.243 % (fluoride ion 0.16 % ) Toothpaste | SY | 1 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83013-344-10 | The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity Toothpast | 100 g in 1 TUBE | GEL | 100 | 1 |
Products#
- The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity Toothpast
- FLUORIDE ION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83013-344 | 83013-344-10 |
Ingredients#
Complete SPL Sections#
Active ingredient
Sodium Fluoride 0.243% (0.14% w/v fluoride ion)
Purpose
Anticavity
Uses
Aids in the prevention of dental cavities.
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.
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