Indications and uses
■ Provides a protection and relief action for healthier teeth and gum. ■ Helps fight and protect against cavities for healthier teeth.
100 toothpast e Night
- Manufacturer
- MGRU | DONG IL PHARMS CO., LTD.
- Effective date
- 2020-12-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:00:31
Label at a glance#
Product100 toothpast e Night
Active ingredientSodium Monofluorophosphate
Label structure8 sections
Dosage and administration
■ Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or three times a day, or as directed by a dentist or physician ■ Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) ■ Children under 2 years: Consult a dentist
Label contents#
Full prescribing information#
ACTIVE INGREDIENT
Sodium Monofluorophosphate 0.75%
INACTIVE INGREDIENTS
D-Sorbitol Solution, Aqua, Silicon Dioxide, Chamomile Extract, Rhatany Essence, Sodium Cocoyl Glutamate, Carboxymethylcellulose Sodium, Peppermint Oil, Aqua Mint Flavor, Grapefruit Seed Extract, L-Menthol, Aluminium Chlorohydroxy Allantoinate, Xylitol, Enzymatically Modified Stevia, Green Tea Extract, Aloe Extract, Eucalyptus Extract, Sage Extract
PURPOSE
Nourishing, Soothing
WARNINGS
Adults and children 2 years of age and older: apply a 1-inch strip of product onto a toothbrush. Brush teeth thoroughly for 3 minutes three times a day (morning, afternoon, evening) or as recommended by a dentist. Do not swallow.
KEEP OUT OF REACH OF CHILDREN
KEEP OUT OF REACH OF CHILDREN
Uses
■ Provides a protection and relief action for healthier teeth and gum.
■ Helps fight and protect against cavities for healthier teeth.
Directions
■ Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or three times a day, or as directed by a dentist or physician
■ Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
■ Children under 2 years: Consult a dentist
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 81307-030-02 | 2024-12-26 | C162847 | 48780-1 | f386c649-cd15-0266-e053-dadaa90a7c1a | dca4a7ff-645f-4ead-ab42-0041ec4de495 |
| 81307-030-02 | 2023-01-30 | C162847 | 48780-1 | f386c649-cd15-0266-e053-dadaa90a7c1a | dca4a7ff-645f-4ead-ab42-0041ec4de495 |
Products#
Every source-derived product name is available through these pages.
- 100 toothpast e Night
- Sodium Monofluorophosphate
- FLUORIDE ION
- Sorbitol
- Water
- Silicon Dioxide
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 81307-030 | 81307-030-01, 81307-030-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Sodium Monofluorophosphate | C810JCZ56Q | ACTIM |
| Sorbitol | 506T60A25R | IACT |
| Water | 059QF0KO0R | IACT |
| Silicon Dioxide | ETJ7Z6XBU4 | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2a37224a-625d-c330-e063-6294a90ac36e | dca4a7ff-645f-4ead-ab42-0041ec4de495 | 2024-12-26 | Warnings | dca4a7ff-645f-4ead-ab42-0041ec4de495 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.