VVARDIS SET SOFT MINT- sodium fluoride, sodium monofluorophosphate kit

VVARDIS SET SOFT MINT by

Drug Labeling and Warnings

VVARDIS SET SOFT 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 Ingredients

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

Purpose Anticavity

Active Ingredients

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

Purpose Anticavity

Use

Aids in the prevention of dental cavities.

KEEP OUT OF REACH OF CHILDREN

Warnings Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

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.

INDICATIONS & USAGE

Supervise children as necessary until capable of using without supervison.

Children under 2 years of age: Consult a dentist or doctor.

INDICATIONS & USAGE

Supervise children as necessary until capable of using without supervision.

Children under 6 years of age: Consult a dentist or doctor.

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 wihtout 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 Ingredients

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

Inactive Ingredients

water, hydrated silica, hydrogenated starch hydrolysate, glycerin, hydroxyapatite, xylitol, sodium coco-sulfate, calcium carbonate, flavor, xanthan gum, citric acid, potassium sorbate, sodium benzoate, leontopodium alpinum flower/leaf extract, rhododendron ferrugineum extract, oligopeptide-104, lactic acid.

Other information

You may report serious side effects to: Swiss Shine Beauty, Inc

651 N. Broad St., Middletown, DE 19709

Tamper evident: Do not use if safety seal is broken or missing.

PRINCIPAL DISPLAY PANEL

WEISSBAD

FRESH AND PROTECT

PURE WHITENING

FLUORIDE MOUTHWASH

SOFT MINT

100 ml e /3.4 FL OZ

EDELWEISS
WHITE AND PROTECT
FLUORIDE TOOTHPASTE
SOFT MINT

NET WT 2.3 OZ (65 g)

INGREDIENTS AND APPEARANCE

VVARDIS SET SOFT MINT 
sodium fluoride, sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79763-004

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79763-004-01	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	07/22/2020

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

Part 1 of 3

FLOURIDE MOUTHWASH SOFT MINT 
sodium flouride mouthwash

Product Information
Item Code (Source)	NDC: 79763-005
Route of Administration	ORAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79763-005-01	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	07/22/2020

Part 2 of 3

FLOURIDE SOFT MINT 
sodium monofluorophosphate paste, dentifrice

Product Information
Item Code (Source)	NDC: 79763-006
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
XYLITOL (UNII: VCQ006KQ1E)
CALCIUM CARBONATE (UNII: H0G9379FGK)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
LEONTOPODIUM ALPINUM FLOWERING TOP (UNII: QQC1AK06RK)
RHODODENDRON FERRUGINEUM WHOLE (UNII: FO6B1S7BZU)
LACTIC ACID (UNII: 33X04XA5AT)
WATER (UNII: 059QF0KO0R)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM COCO-SULFATE (UNII: 3599J29ANH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79763-006-01	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	07/22/2020

Part 3 of 3

INSTANT BRIGHT AND WHITE CONCENTRATE 
other oral hygiene products gel

Product Information
Route of Administration	ORAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	CALCIUM CARBONATE (UNII: H0G9379FGK)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)
INGR	WATER (UNII: 059QF0KO0R)
INGR	HYDRATED SILICA (UNII: Y6O7T4G8P9)
INGR	CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
INGR	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
INGR	TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
INGR	POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
INGR	CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
INGR	SACCHARIN SODIUM (UNII: SB8ZUX40TY)
INGR	SORBITOL (UNII: 506T60A25R)
INGR	PENTYLENE GLYCOL (UNII: 50C1307PZG)
INGR	MANNITOL (UNII: 3OWL53L36A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		2.6 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		07/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/22/2020

Labeler - Swiss Shine Beauty AG (480422958)

Establishment
Name	Address	ID/FEI	Business Operations
System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH		328825757	manufacture(79763-004)

Establishment
Name	Address	ID/FEI	Business Operations
Marvinpac SA		482060329	pack(79763-004)