FDA.reportPublic FDA data

Fluoride Strong Mint

Manufacturer
Swiss Shine Beauty AG | System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH | Marvinpac SA
Effective date
2022-01-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:47:26

Label at a glance#

ProductFluoride Strong Mint
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

sodium monofluorophosphate 0.88% Anticavity

(0.115% W/V fluoride)

OTC - PURPOSE SECTION

Use

  • Aids in the prevention of dental cavities

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

INDICATIONS & USAGE SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.

WARNINGS 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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults and children 2 years of age and older:Brush teeth thoroughly, preferable 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

INACTIVE INGREDIENT SECTION

Inactive Ingredients

water, hydrated silica, sorbitol, glycerin, hydroxyapatite, xylitol, sodium coco-sulfate, xanthan gum, calcium carbonate, citric acid, flavor, zinc lactate, menthol, potassium sorbate, sodium benzoate, leontopodium alpinum flower/leaf extract, rhododendron ferrugineum extract, oligopeptide-104

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

vVardis Switzerland

edelwiess

white and protect

Fluoride Toothpaste Strong Mint

NET WT 2.3 OZ (65 g)

vVardis Edelweiss strong mintvVardis Edelweiss strong mint

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1546238sodium monofluorophosphate 0.88 % ToothpastePSN3
1546238sodium monofluorophosphate 0.0088 MG/MG ToothpasteSCD3
1546238sodium monofluorophosphate 0.88 % (fluoride ion 0.115 % )ToothpasteSY3
1546238sodium monofluorophosphate 0.88 % ToothpasteSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79763-007-012023-07-28C16284748780-10191ceaa-6eb2-198a-e063-dbdaa90aec3eFluoride Strong Mint
79763-007-022023-07-28C16284748780-10191ceaa-6eb2-198a-e063-dbdaa90aec3eFluoride Strong Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79763-007-01Fluoride Strong Mint65 g in 1 TUBEPASTE653
79763-007-02Fluoride Strong Mint6.5 g in 1 TUBEPASTE6.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79763-007FLUORIDE STRONG MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE [SWISS SHINE BEAUTY AG]3Legacy NDC, 2 package rows20220123_b1a5b43b-d5ea-3980-e053-2995a90a3b01.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79763-00779763-007-01, 79763-007-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC LACTATE2GXR25858YIACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM COCO-SULFATE3599J29ANHIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CALCIUM CARBONATEH0G9379FGKIACT
XYLITOLVCQ006KQ1EIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWERING TOPQQC1AK06RKIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
SODIUM BENZOATEOJ245FE5EUIACT
RHODODENDRON FERRUGINEUM WHOLEFO6B1S7BZUIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT

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
d60811f7-b1dc-719b-e053-2a95a90ab2fcb1a5b43b-d5ea-3980-e053-2995a90a3b012022-01-20WarningsExact identifier
spl id: d60811f7-b1dc-719b-e053-2a95a90ab2fc
spl set id: b1a5b43b-d5ea-3980-e053-2995a90a3b01

Reported adverse events (FAERS/openFDA)#

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