FDA.reportPublic FDA data

Dental Kit Soft Mint

Manufacturer
vVARDIS AG
Effective date
2022-03-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:48:41

Label at a glance#

ProductDental Kit Soft Mint
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

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

INDICATIONS & USAGE SECTION

Use
Aids in the prevention of dental cavities.

WARNINGS SECTION

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.

OTHER SAFETY INFORMATION

Other Information

You may report serious side effects to : vVardis, Inc.

651 N. Broad St., Middletown, DE 19709

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

vVARDIS

Switzerland

Dental Kit by VVARDIS

One Toothbrush

One Fluoride toothpaste

Soft Mint

NET. WT. 0.2 OZ (6.5g)

dental kit softdental kit soft

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1546238sodium monofluorophosphate 0.88 % ToothpastePSN1
1546238sodium monofluorophosphate 0.0088 MG/MG ToothpasteSCD1
1546238sodium monofluorophosphate 0.88 % (fluoride ion 0.115 % )ToothpasteSY1
1546238sodium monofluorophosphate 0.88 % ToothpasteSY1

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
82615-001-012023-07-28C16284748780-10191ceaa-653a-198a-e063-dbdaa90aec3eDental Kit Soft Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82615-001-01Dental Kit Soft Mint1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82615-001DENTAL KIT SOFT MINT (SODIUM MONOFLUOROPHOSPHATE) KIT [VVARDIS AG]1Legacy NDC, 1 package rows20220310_d9a63ffa-4174-76f0-e053-2a95a90ab7c3.zip
82615-002DENTAL KIT SOFT MINT (SODIUM MONOFLUOROPHOSPHATE) KIT [VVARDIS AG]1Unmatched20220310_d9a63ffa-4174-76f0-e053-2a95a90ab7c3.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82615-00182615-001-01
82615-00282615-002-01

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
XANTHAN GUMTTV12P4NEEIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
HYDROGENATED STARCH HYDROLYSATE27F77DSJ5VIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
XYLITOLVCQ006KQ1EIACT
SODIUM COCO-SULFATE3599J29ANHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
LEONTOPODIUM ALPINUM FLOWERING TOPQQC1AK06RKIACT
CALCIUM CARBONATEH0G9379FGKIACT
GLYCERINPDC6A3C0OXIACT
RHODODENDRON FERRUGINEUM WHOLEFO6B1S7BZUIACT
LACTIC ACID33X04XA5ATIACT
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
d9a63ffa-4175-76f0-e053-2a95a90ab7c3d9a63ffa-4174-76f0-e053-2a95a90ab7c32022-03-07WarningsExact identifier
spl id: d9a63ffa-4175-76f0-e053-2a95a90ab7c3
spl set id: d9a63ffa-4174-76f0-e053-2a95a90ab7c3

Reported adverse events (FAERS/openFDA)#

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