FDA.reportPublic FDA data

VVARDIS SET 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
2
Source
full-release
Hydrated at
2026-05-31 23:41:59

Label at a glance#

ProductVVARDIS SET SOFT MINT
Active ingredientSODIUM FLUORIDE, SODIUM MONOFLUOROPHOSPHATE
Label structure15 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.05% (0.02% W/V fluoride ion)

Purpose Anticavity

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.88% (0.115% W/V flouride ion)

Purpose Anticavity

Use

OTC - PURPOSE SECTION

Aids in the prevention of dental cavities.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings 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.

INDICATIONS & USAGE SECTION

Supervise children as necessary until capable of using without supervison.

Children under 2 years of age: Consult a dentist or doctor.

INDICATIONS & USAGE SECTION

Supervise children as necessary until capable of using without supervision.

Children under 6 years of age: Consult a dentist or doctor.

WARNINGS SECTION

Warnings 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.

WARNINGS SECTION

Warnings 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

  • Shake well before use.
  • Adults and children 6 years of age and older: Use once a day after brushing your 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 wihtout supervision.
  • Children under 6 years of age: Consult a dentist or doctor.

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 supervison.
  • Children under 2 years of age: consult a dentist or doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, glycerine, 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Other information

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WEISSBAD

FRESH AND PROTECT

PURE WHITENING

FLUORIDE MOUTHWASH

SOFT MINT

100 ml e /3.4 FL OZ

EDELWEISS
WHITE AND PROTECT
FLUORIDE TOOTHPASTE
SOFT MINT


NET WT 2.3 OZ (65 g)

VVardis Soft mint backVVardis Soft mint back

Soft mint Set front panelSoft mint Set front panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN2
1546238sodium monofluorophosphate 0.88 % ToothpastePSN2
240698sodium fluoride 0.5 MG/ML MouthwashSCD2
1546238sodium monofluorophosphate 0.0088 MG/MG ToothpasteSCD2
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY2
1546238sodium monofluorophosphate 0.88 % (fluoride ion 0.115 % )ToothpasteSY2
1546238sodium monofluorophosphate 0.88 % ToothpasteSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79763-004-012023-01-30C16284748780-1f386c649-9b84-0266-e053-dadaa90a7c1aVVARDIS SET SOFT MINT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79763-004-01VVARDIS SET SOFT MINT1 in 1 KITKIT12
79763-005-01VVARDIS SET SOFT MINT100 mL in 1 BOTTLEMOUTHWASH100 mL0.05 g in 100mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79763-004VVARDIS SET SOFT MINT (SODIUM FLUORIDE, SODIUM MONOFLUOROPHOSPHATE) KIT [SWISS SHINE BEAUTY AG]2Legacy NDC, 2 package rows20210820_ab0ef0ce-e6a8-2707-e053-2995a90aef43.zip
79763-005VVARDIS SET SOFT MINT (SODIUM FLUORIDE, SODIUM MONOFLUOROPHOSPHATE) KIT [SWISS SHINE BEAUTY AG]2Unmatched20210820_ab0ef0ce-e6a8-2707-e053-2995a90aef43.zip
79763-006VVARDIS SET SOFT MINT (SODIUM FLUORIDE, SODIUM MONOFLUOROPHOSPHATE) KIT [SWISS SHINE BEAUTY AG]2Unmatched20210820_ab0ef0ce-e6a8-2707-e053-2995a90aef43.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79763-00479763-004-01
79763-00579763-005-01
79763-00679763-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 44 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLOXAMER 407TUF2IVW3M2IACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYDROCHLORIC ACIDQTT17582CBIACT
WATER059QF0KO0RIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
XYLITOLVCQ006KQ1EIACT
SODIUM CITRATE1Q73Q2JULRIACT
ZINC LACTATE2GXR25858YIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
GLYCERINPDC6A3C0OXIACT
XYLITOLVCQ006KQ1EIACT
CALCIUM CARBONATEH0G9379FGKIACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM BENZOATEOJ245FE5EUIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
LEONTOPODIUM ALPINUM FLOWERING TOPQQC1AK06RKIACT
RHODODENDRON FERRUGINEUM WHOLEFO6B1S7BZUIACT
LACTIC ACID33X04XA5ATIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
WATER059QF0KO0RIACT
HYDROGENATED STARCH HYDROLYSATE27F77DSJ5VIACT
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM COCO-SULFATE3599J29ANHIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CALCIUM CARBONATEH0G9379FGKINGR
CITRIC ACID MONOHYDRATE2968PHW8QPINGR
SODIUM HYDROXIDE55X04QC32IINGR
CALCIUM GLYCEROPHOSPHATEXWV9Z12C1CINGR
WATER059QF0KO0RINGR
HYDRATED SILICAY6O7T4G8P9INGR
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSL11K75P92JINGR
FD&C BLUE NO. 1H3R47K3TBDINGR
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28INGR
POLYETHYLENE GLYCOL 400B697894SGQINGR
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311INGR

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
c9ee4e8d-d528-9960-e053-2995a90a29bcab0ef0ce-e6a8-2707-e053-2995a90aef432021-08-19WarningsExact identifier
spl id: c9ee4e8d-d528-9960-e053-2995a90a29bc
spl set id: ab0ef0ce-e6a8-2707-e053-2995a90aef43

Reported adverse events (FAERS/openFDA)#

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