VVARDIS SET STRONG MINT- sodium monofluorophosphate, sodium fluoride kit

VVARDIS SET STRONG MINT by

Drug Labeling and Warnings

VVARDIS SET STRONG MINT by is a Otc medication manufactured, distributed, or labeled by Swiss Shine Beauty AG, System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH, Marvinpac SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Mouthwash

Active ingredients

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

ACTIVE INGREDIENT

Toothpaste

Active Ingredients

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

PURPOSE

Use

Aids in the prevention of dental cavities.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

Supervise children as necessary until capable of using without supervison.

WARNINGS

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

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

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 without supervision.
Children under 6 years of age: Consult a dentist or doctor.

DOSAGE & ADMINISTRATION

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 INGREDIENT

Inactive Ingredients

water, glycerin, propylene glycol, xylitol, peg-40 hydrogenated castor oil, flavor, sodium citrate, zinc lactate, poloxamer 407, chlorhexidine digluconate, citric acid, hydrochloric acid, oligopeptide-104, sodium hydroxide

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

VVardis Set Strong Mint

INGREDIENTS AND APPEARANCE

VVARDIS SET STRONG MINT 
sodium monofluorophosphate, sodium fluoride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79763-008

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79763-008-01	1 in 1 KIT	10/14/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	100 mL  in 100
Part 2	1 TUBE	65 g  in 65
Part 3	1 BOTTLE, WITH APPLICATOR	2.6 g  in 100

Part 1 of 3

PURE WHITENING FLUORIDE MOUTHWASH STRONG MINT 
sodium fluoride liquid

Product Information
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLOXAMER 407 (UNII: TUF2IVW3M2)
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROCHLORIC ACID (UNII: QTT17582CB)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ZINC LACTATE (UNII: 2GXR25858Y)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		100 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/15/2020

Part 2 of 3

FLUORIDE STRONG MINT 
sodium monofluorophosphate gel

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.88 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		65 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	10/15/2020

Part 3 of 3

INSTANT BRIGHT AND WHITE CONCENTRATE FOR TEETH 
other oral hygiene products gel

Product Information
Route of Administration	DENTAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	SORBITOL (UNII: 506T60A25R)
INGR	HYDRATED SILICA (UNII: Y6O7T4G8P9)
INGR	WATER (UNII: 059QF0KO0R)
INGR	MANNITOL (UNII: 3OWL53L36A)
INGR	PENTYLENE GLYCOL (UNII: 50C1307PZG)
INGR	POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
INGR	TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
INGR	CALCIUM CARBONATE (UNII: H0G9379FGK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		2.6 g in 1 BOTTLE, WITH APPLICATOR; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		10/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part356	10/14/2020

Labeler - Swiss Shine Beauty AG (480422958)

Establishment
Name	Address	ID/FEI	Business Operations
System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH		328825757	manufacture(79763-008)

Establishment
Name	Address	ID/FEI	Business Operations
Marvinpac SA		482060329	pack(79763-008)