FDA.reportPublic FDA data

Fluoride Mouthwash Soft Mint

Manufacturer
Swiss Shine Beauty AG | System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH | Marvinpac SA
Effective date
2020-08-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:23:37

Label at a glance#

ProductFluoride Mouthwash Soft Mint
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Sodium fluoride 0.05% (0.02% 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.

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

INDICATIONS & USAGE SECTION

Do not swallow the rinse

WARNINGS SECTION

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • Shake well before use.
  • Adults and children 6 years of age and older: Use once a day after brushing yout teeth with a toothpaste.
  • Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out.
  • Do not swallow the rinse.
  • Do not eat or drink for 30 minutes after rinsing.
  • Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
  • Supervise children as necessary until capable of using without supervision.
  • Children under 6 years of age: Consult a dentist or doctor.

OTHER SAFETY INFORMATION

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

651 N. Broad St., Middletown, DE 19709

  • Tamper evident: Do not use if safety seal is broken or missing.

INACTIVE INGREDIENT SECTION

Inactive ingredients

water, glycerin, propylene glycol, xylitol, peg-40 hydrogenated castor oil, sodium citrate, flavor, zinc lactate, poloxamer 407, chlorhexidine digluconate, citric acid, hydrochloric acid, oligopeptide-104, sodium hydroxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

vVARDIS

SWITZERLAND

WEISSBAD

FRESH AND PROTECT

PURE WHITENING

FLUORIDE MOUTHWASH

SOFT MINT

IMPORTANT: READ DIRECTIONS FOR PROPER USE

3.4 FL OZ / 100 ml e

100 Fluoride Mouthwash100 Fluoride Mouthwash

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN2
240698sodium fluoride 0.5 MG/ML MouthwashSCD2
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79763-002-012023-01-30C16284748780-1f386c649-e709-0266-e053-dadaa90a7c1aFluoride Mouthwash Soft Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79763-002-01Fluoride Mouthwash Soft Mint100 mL in 1 BOTTLEMOUTHWASH1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79763-002FLUORIDE MOUTHWASH SOFT MINT (SODIUM FLUORIDE) MOUTHWASH [SWISS SHINE BEAUTY AG]2Legacy NDC, 1 package rows20200804_aaf788de-6666-3e5b-e053-2a95a90a403e.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79763-00279763-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM HYDROXIDE55X04QC32IIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ZINC LACTATE2GXR25858YIACT
POLOXAMER 407TUF2IVW3M2IACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
WATER059QF0KO0RIACT
XYLITOLVCQ006KQ1EIACT
HYDROCHLORIC ACIDQTT17582CBIACT
GLYCERINPDC6A3C0OXIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB

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
abfd59bf-0a3d-2168-e053-2995a90adef7aaf788de-6666-3e5b-e053-2a95a90a403e2020-08-03WarningsExact identifier
spl id: abfd59bf-0a3d-2168-e053-2995a90adef7
spl set id: aaf788de-6666-3e5b-e053-2a95a90a403e

Reported adverse events (FAERS/openFDA)#

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