vVARDIS Switzerland Edelweiss White and Protect Fluoride Toothpaste Strong Mint

vVARDIS Switzerland Edelweiss White and Protect Fluoride Tooth Strong Mint by

Drug Labeling and Warnings

vVARDIS Switzerland Edelweiss White and Protect Fluoride Tooth Strong Mint by is a Otc medication manufactured, distributed, or labeled by Marvinpac SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VVARDIS SWITZERLAND EDELWEISS WHITE AND PROTECT FLUORIDE TOOTH STRONG MINT- sodium monofluorophosphate paste 
Marvinpac SA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

vVARDIS Switzerland Edelweiss White and Protect Fluoride Toothpaste Strong Mint

Drug Facts

Active ingredients

Sodium monofluorophosphate 0.88%

(0.115% W/V fluoride ion)

Purpose

Anticavity

Use

• Aids in the prevention of dental cavities.

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

• 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

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

651 N. Broad St., Middletown, DE 19709

Inactive ingredients

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:

VVARDIS SWITZERLAND EDELWEISS WHITE AND PROTECT FLUORIDE TOOTH STRONG MINT 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90073-005
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.15 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM COCO-SULFATE (UNII: 3599J29ANH)
XANTHAN GUM (UNII: TTV12P4NEE)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ZINC LACTATE (UNII: 2GXR25858Y)
MENTHOL (UNII: L7T10EIP3A)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWERING TOP (UNII: QQC1AK06RK)
RHODODENDRON FERRUGINEUM WHOLE (UNII: FO6B1S7BZU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90073-005-01	1 in 1 BOX	11/01/2020
1		65 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/01/2020

Labeler - Marvinpac SA (482060329)

Revised: 12/2020

Document Id: b57d0390-ac6e-0b69-e053-2a95a90a27b8

34390-5

Set id: b57d0e51-630e-09a7-e053-2a95a90a43b8

Version: 1

Effective Time: 20201202

 <