FDA.reportPublic FDA data

Fluoride Soft Mint

Manufacturer
Swiss Shine Beauty AG | System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH | Marvinpac SA
Effective date
2021-08-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:41:58

Label at a glance#

ProductFluoride Soft Mint
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Sodium monofluorophosphate 0.88% (0.115% W/V fluoride Ion)

Purpose Anticavity

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 age.

If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Use
Aids in the prevention of dental cavities.

WARNINGS SECTION

Warnings

Keep our 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, 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.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

water, hydrated silica, hydrogenated strach hydrolysate, glycerin, hydroxyapatite, xylitol, sodium coco-sulfate, calcium carbonate, flavor, xanthan gum, citric acid, potasium sorbate, sodium benzoate, leontopodium alpinum flower/leaf extract, rhododendron ferrugineum extract, oligopeptide-104, lactic acid

OTHER SAFETY INFORMATION

Other Information

You may report serious side effects to : Swiss Shine Beauty, Inc.

651 N. Broad St., Middletown, DE 19709

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

vVARDIS

SWITZERLAND

EDELWEISS

WHITE AND PROTECT

FLUORIDE TOOTHPASTE

SOFT MINT

NET WT 2.3OZ (65 g)

65g Fluoride Toothpaste65g Fluoride Toothpaste

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79763-003-012023-01-30C16284748780-1f386c649-f4d0-0266-e053-dadaa90a7c1aFluoride Toothpaste Soft Mint
79763-003-022023-01-30C16284748780-1f386c649-f4d0-0266-e053-dadaa90a7c1aFluoride Toothpaste Soft Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79763-003-01Fluoride Soft Mint65 g in 1 TUBEPASTE, DENTIFRICE653
79763-003-02Fluoride Soft Mint6.5 g in 1 TUBEPASTE, DENTIFRICE6.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79763-003FLUORIDE SOFT MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SWISS SHINE BEAUTY AG]3Legacy NDC, 2 package rows20210820_ab0c542c-1afb-0707-e053-2995a90a5eb4.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79763-00379763-003-01, 79763-003-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM SORBATE1VPU26JZZ4IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
XYLITOLVCQ006KQ1EIACT
SODIUM COCO-SULFATE3599J29ANHIACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
LACTIC ACID33X04XA5ATIACT
CALCIUM CARBONATEH0G9379FGKIACT
WATER059QF0KO0RIACT
HYDROGENATED STARCH HYDROLYSATE27F77DSJ5VIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
LEONTOPODIUM ALPINUM FLOWERING TOPQQC1AK06RKIACT
HYDRATED SILICAY6O7T4G8P9IACT
RHODODENDRON FERRUGINEUM WHOLEFO6B1S7BZUIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM

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
c9ed6374-1f64-d74d-e053-2995a90a0509ab0c542c-1afb-0707-e053-2995a90a5eb42021-08-19WarningsExact identifier
spl id: c9ed6374-1f64-d74d-e053-2995a90a0509
spl set id: ab0c542c-1afb-0707-e053-2995a90a5eb4

Reported adverse events (FAERS/openFDA)#

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