Indications and uses
Uses: Helps protect against cavities.
PLUS153 Toothpast e
- Manufacturer
- SGS Inc.
- Effective date
- 2017-07-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:51:51
Label at a glance#
ProductPLUS153 Toothpast e
Active ingredientSodium monofluorophosphate
Label structure8 sections
Dosage and administration
Directions: Supervise children as necessary until capable of using without supervision. - Adults and children 6 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, Or as directed by a dentist or a physician - children under 12 years: instruct in good brushing and rinsing habits (to minimize swallowing) - children under 6 years: do not use unless directed by a dentist...
Label contents#
Full prescribing information#
ACTIVE INGREDIENT
Active ingredients: Sodium monofluorophosphate 0.74%
INACTIVE INGREDIENT
Inactive ingredients: Silica, Aminocaproic Acid, Allantoine Chlorohydroxy Aluminum, PEG-1500, D-Sorbitol, Glycerin, Carboxymethylcellulose Sodium, Sodium Lauryl Sulfate, Xylitol, Sodium Saccharin, Sophora Angustifolia Root Extract, Glycyrrhiza Glabra Root Extract, Sodium Benzoate, L-Menthol, Carvone, Anethole, Peppermint Oil, Silver, Water
PURPOSE
Purpose: Anticavity
WARNINGS
Warnings: For external use only If more than used for brushing is accidently swallowed get medical help or contact a poison control center immediately Avoid contact with eyes.
KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children under 6 years of age.
Uses
Uses: Helps protect against cavities.
Directions
Directions:
Supervise children as necessary until capable of using without supervision.
- Adults and children 6 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, Or as directed by a dentist or a physician
- children under 12 years: instruct in good brushing and rinsing habits (to minimize swallowing)
- children under 6 years: do not use unless directed by a dentist or a physician
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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 |
|---|---|---|---|---|---|
| 71553-010-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-dbdd-f424-e053-dadaa90a57ce | 4a33a814-dc29-476a-a1af-4b1714be5ba2 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71553-010-01 | PLUS153 Toothpast e | 40 g in 1 TUBE | PASTE, DENTIFRICE | 40 | 1 | |
| 71553-010-02 | PLUS153 Toothpast e | 1 in 1 POUCH | PASTE, DENTIFRICE | 1 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- PLUS153 Toothpast e
- Sodium monofluorophosphate
- FLUORIDE ION
- Aminocaproic Acid
- Glycerin
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71553-010 | 71553-010-01, 71553-010-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Sodium monofluorophosphate | C810JCZ56Q | ACTIM |
| Aminocaproic Acid | U6F3787206 | IACT |
| Glycerin | PDC6A3C0OX | 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 |
|---|---|---|---|---|---|---|
| 03f36f87-b82d-48a6-9fef-536501aa87e6 | 4a33a814-dc29-476a-a1af-4b1714be5ba2 | 2017-07-07 | Warnings | 03f36f87-b82d-48a6-9fef-536501aa87e6 4a33a814-dc29-476a-a1af-4b1714be5ba2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.