Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Sodium Monofluorophosphate
OTC - PURPOSE SECTION
For dental care
SALTRAIN TOOTH
- Manufacturer
- K.Boeun Pharmaceutical Co.,Ltd.
- Effective date
- 2020-11-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:33:25
Key Label Information#
Uses
INDICATIONS & USAGE SECTION
Apply an appropriate amount to your toothbrush and brush your teeth by brushing
Warnings
WARNINGS SECTION
Keep out of reach of children under 6 years old. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
For dental use only
Other Label Information
INACTIVE INGREDIENT SECTION
Precipitated Calcium Carbonate, Dibasic Calcium Phosphate, Aminocaproic Acid, Aluminium Chlorohydroxy Allantoinate, D-Sorbitol Solution, Concentrated Glycerin, Polyethylene Glycol 1500, Xanthangum, Sodium Cocoyl Glutamate, Silicon Dioxide, Titanium Oxide, Enzymatically Modified Stevia, Xylitol, Sodium Chloride, Ascorbic Acid, Mentha Oil, l-Menthol, Spearmint Oil, Water
Label Images#
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 83904ae6-37b6-4aa3-b6c9-663bc8d6ab8d | Product name | 9 | 20250103 |
| e89c33e6-9224-49b0-4d80-05239f586f24 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 74724-0021-1 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-ae07-d83d-e063-dadaa90ab31f | b3cec2cd-6a67-68ca-e053-2995a90ad738 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 74724-0021-1 | SALTRAIN TOOTH | 100 g in 1 TUBE | PASTE | 100 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 74724-0021 | SALTRAIN TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE [K.BOEUN PHARMACEUTICAL CO.,LTD.] | 1 | Legacy NDC, 1 package rows | 20201112_b3cec2cd-6a67-68ca-e053-2995a90ad738.zip |
Products#
- SALTRAIN TOOTH
- FLUORIDE ION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 74724-0021 | 74724-0021-1 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| XYLITOL | VCQ006KQ1E | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM MONOFLUOROPHOSPHATE | C810JCZ56Q | ACTIM |
| AMINOCAPROIC ACID | U6F3787206 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
Complete SPL Sections#
OTC - ACTIVE INGREDIENT SECTION
Sodium Monofluorophosphate
OTC - PURPOSE SECTION
For dental care
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
INDICATIONS & USAGE SECTION
Apply an appropriate amount to your toothbrush and brush your teeth by brushing
WARNINGS SECTION
Keep out of reach of children under 6 years old. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
INACTIVE INGREDIENT SECTION
Precipitated Calcium Carbonate, Dibasic Calcium Phosphate, Aminocaproic Acid, Aluminium Chlorohydroxy Allantoinate, D-Sorbitol Solution, Concentrated Glycerin, Polyethylene Glycol 1500, Xanthangum, Sodium Cocoyl Glutamate, Silicon Dioxide, Titanium Oxide, Enzymatically Modified Stevia, Xylitol, Sodium Chloride, Ascorbic Acid, Mentha Oil, l-Menthol, Spearmint Oil, Water
DOSAGE & ADMINISTRATION SECTION
For dental use only