vVARDIS Switzerland Edelweiss White and Protect Fluoride Tooth Strong Mint

Manufacturer
Marvinpac SA
Effective date
2020-12-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:01:43

Label at a glance#

ProductvVARDIS Switzerland Edelweiss White and Protect Fluoride Tooth Strong Mint
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure7 sections

Dosage and administration

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 a doctor.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.88%

(0.115% W/V fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

  • Aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

Keep out of reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 a doctor.

Other information

SPL UNCLASSIFIED SECTION

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

651 N. Broad St., Middletown, DE 19709

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, hydrated silica, sorbitol, glycerin, hydroxyyapatite, xylitol, sodium coco-sulfate, xanthan gum, calcium carbonate, citric acid, flavor, zinc lactate, menthol, potassium sorbate, sodium benzoate, leontopodium alpinum flower/leaf extract, rhododendron ferruginem extract, oligopeptide-104

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBoxLabelLabel

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
90073-00590073-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

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
b57d0390-ac6e-0b69-e053-2a95a90a27b8b57d0e51-630e-09a7-e053-2a95a90a43b82020-12-02WarningsExact identifier
spl id: b57d0390-ac6e-0b69-e053-2a95a90a27b8
spl set id: b57d0e51-630e-09a7-e053-2a95a90a43b8

Reported adverse events (FAERS/openFDA)#

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