FDA.reportPublic FDA data

Dental Kit Strong Mint

Manufacturer
vVardis AG
Effective date
2022-03-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:48:40

Label at a glance#

ProductDental Kit Strong Mint
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

sodium monofluorophosphate 0.88%

(0.115% W/W 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 of age.

INDICATIONS & USAGE SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.

WARNINGS SECTION

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

  • Adults and children 2 years of age and older:Brush teeth thoroughly, preferable 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, sorbitol, glycerin, hydroxyapatite, xylitol, sodium coco-sulfate, xanthan gum, calcium carbonate, citric acid, flavor, zinc lactate, menthol, potassium sorbate, sodium benzoate, leontopodium alpinum flower/leaf extract, rhododendron ferrugineum extract, oligopeptide-104

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

vVARDIS

Switzerland

Dental Kit by VVARDIS

One Toothbrush

One Fluoride toothpaste

Strong Mint

NET. WT. 0.2 OZ (6.5g)

Dental Kit Strong MintDental Kit Strong Mint

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82615-003-012023-07-28C16284748780-10191ceaa-62a7-198a-e063-dbdaa90aec3eDental Kit Strong Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82615-003-01Dental Kit Strong Mint1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82615-003DENTAL KIT STRONG MINT (SODIUM MONOFLUOROPHOSPHATE) KIT [VVARDIS AG]1Legacy NDC, 1 package rows20220310_d968c8ba-d02b-5158-e053-2995a90a7946.zip
82615-004DENTAL KIT STRONG MINT (SODIUM MONOFLUOROPHOSPHATE) KIT [VVARDIS AG]1Unmatched20220310_d968c8ba-d02b-5158-e053-2995a90a7946.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
82615-00382615-003-01
82615-00482615-004-01

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
SORBITOL506T60A25RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
RHODODENDRON FERRUGINEUM WHOLEFO6B1S7BZUIACT
XYLITOLVCQ006KQ1EIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
SODIUM COCO-SULFATE3599J29ANHIACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
LEONTOPODIUM ALPINUM FLOWERING TOPQQC1AK06RKIACT
ZINC LACTATE2GXR25858YIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
CALCIUM CARBONATEH0G9379FGKIACT

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
d968c8ba-d02c-5158-e053-2995a90a7946d968c8ba-d02b-5158-e053-2995a90a79462022-03-04WarningsExact identifier
spl id: d968c8ba-d02c-5158-e053-2995a90a7946
spl set id: d968c8ba-d02b-5158-e053-2995a90a7946

Reported adverse events (FAERS/openFDA)#

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