Toothpaste tablets with fluoride

Manufacturer
Mintly Inc.
Effective date
2022-11-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:47:28

Label at a glance#

ProductFLUORIDE
Active ingredientSodium Fluoride
Label structure11 sections

Dosage and administration

Adults and children 2 years of age and older: chew tablet briefly and brush teeth thoroughly, preferably after each meal or at least twice a day or 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.

Storage and handling

Store at 68-77°F (20-25°C). Protect from excessive moisture.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.21% (0.30 mg fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: chew tablet briefly and brush teeth thoroughly, preferably after each meal or at least twice a day or 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 information

STORAGE AND HANDLING SECTION

Store at 68-77°F (20-25°C).

Protect from excessive moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

microcrystalline cellulose, sodium bicarbonate, silica, sodium lauroyl glutamate, magnesium stearate, natural mint flavor, menthol, xanthan gum, stevioside, citric acid

Questions?

OTC - QUESTIONS SECTION

Call 888-478-6710

SPL UNCLASSIFIED SECTION

DIST. BY MINTLY INC., PRINCETON, NJ 08540

PRINCIPAL DISPLAY PANEL - 240 Tablet Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mintly

TOOTHPASTE
TABLETS

with fluoride

NATURAL MINT

240
TABLETS

2.6 OZ (74.9g)

Principal Display Panel - 240 Tablet Jar Label
Principal Display Panel - 240 Tablet Jar Label

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82149-001FLUORIDE (SODIUM FLUORIDE) TABLET [MINTLY INC.]3Legacy NDC20221119_4deac778-cb95-4c81-b3d7-ead8d956b312.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82149-00182149-001-01, 82149-001-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
18656ae0-bd97-4a3a-8025-b23c165333524deac778-cb95-4c81-b3d7-ead8d956b3122022-11-16WarningsExact identifier
spl id: 18656ae0-bd97-4a3a-8025-b23c16533352
spl set id: 4deac778-cb95-4c81-b3d7-ead8d956b312

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.