FDA.reportPublic FDA data

Unpaste

Manufacturer
Farmina sp. z.o.o. | Farmina sp. z o.o., Zaklad w Myslenicach
Effective date
2023-05-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:31:38

Label at a glance#

ProductUnpaste
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Dosage and administration

Adults and children 6 years of age and older; chew one tablet briefly and brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Do not swallow the tablet. Supervise children under 6 years of age for brushing and rinsing.

Storage and handling

Store at 25-30°C (68-77°F). Protect from excessive moisture.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.62mg (28 mg flouride ion)

Purpose

OTC - PURPOSE SECTION

Anti-cavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

  • When using this product, if irritation or sensitivity occurs discontinue use.
  • Keep out of the reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

OTC - WHEN USING SECTION

When using this product, if irritation or sensitivity occurs discontinue use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 years of age and older; chew one tablet briefly and brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Do not swallow the tablet.
  • Supervise children under 6 years of age for brushing and rinsing.

Other information

STORAGE AND HANDLING SECTION

Store at 25-30°C (68-77°F). Protect from excessive moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Microcrystalline Cellulose, Sodium bicarbonate (Baking Soda), Silica, Sodium Lauryl Glutamate, Magnesium Stearate, Natural Mint Flavor, Menthol, Xanthan Gum, Stevia (Stevioside), Citric Acid

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bulk Label Mint 04Bulk Label Mint 04

120kg drum, NDC: 68984-122-04

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68984-122-042026-01-27C16284748780-11030e365-69d6-111a-e063-dadaa90a10e2Farmina Mint Tabs
68984-122-042025-01-30C16284748780-11030e365-69d6-111a-e063-dadaa90a10e2Farmina Mint Tabs
68984-122-042024-01-30C16284748780-11030e365-69d6-111a-e063-dadaa90a10e2Farmina Mint Tabs

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68984-122UNPASTE (ZERO WASTE FLUORIDE MINT TOOTH TABS) TABLET, CHEWABLE [FARMINA SP. Z.O.O.]4Legacy NDC20230510_ee8eb995-5d7f-2ecd-e053-2a95a90af04a.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68984-12268984-122-04

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
STEVIA LEAF6TC6NN0876IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MINTFV98Z8GITPIACT
MENTHOL, (+)-C6B1OE8P3WIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM LAUROYL GLUTAMATENCX1UU2D33IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
MAGNESIUM STEARATE70097M6I30IACT

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
49674437-4e4f-1b98-e063-6294a90abde6ee8eb995-5d7f-2ecd-e053-2a95a90af04a2026-01-27WarningsExact identifier
spl set id: ee8eb995-5d7f-2ecd-e053-2a95a90af04a

Reported adverse events (FAERS/openFDA)#

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