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

Key Label Information#

Active Ingredients And Purpose

Active Ingredients

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

Active Ingredients

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

Use

Aids in the prevention of dental cavities.

Uses

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

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.

Directions And Dosage

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.

Other Label Information

Inactive Ingredients

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

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.

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)

Label Images#

200626_vVardis_Set_Soft Mint
200626_vVardis_Set_Soft Mint
200626_Set_Soft Front panel
200626_Set_Soft 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#

NDC Codes#

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

Ingredients#

Complete SPL Sections#

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

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

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

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

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 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 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

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

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

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)

Source Document#

Source XML