VVARDIS SET SOFT MINT- sodium fluoride, sodium monofluorophosphate 
Swiss Shine Beauty AG

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.

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VVARDIS SET SOFT MINT

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.

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.

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.

Supervise children as necessary until capable of using without supervison.

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

Supervise children as necessary until capable of using without supervision.

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

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 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

Directions

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.

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)

VVardis Soft mint back

Soft mint Set front panel

VVARDIS SET SOFT MINT 
sodium fluoride, sodium monofluorophosphate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79763-004
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79763-004-011 in 1 KIT; Type 1: Convenience Kit of Co-Package07/22/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 100 mL
Part 21 TUBE 65 g
Part 31 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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79763-005-01100 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/22/2020
Part 2 of 3
FLOURIDE SOFT MINT 
sodium monofluorophosphate paste, dentifrice
Product Information
Item Code (Source)NDC:79763-006
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.88 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79763-006-0165 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/22/2020
Part 3 of 3
INSTANT BRIGHT AND WHITE CONCENTRATE 
other oral hygiene products gel
Product Information
Route of AdministrationORAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRCALCIUM CARBONATE (UNII: H0G9379FGK)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRCALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)  
INGRWATER (UNII: 059QF0KO0R)  
INGRHYDRATED SILICA (UNII: Y6O7T4G8P9)  
INGRCALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
INGRFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
INGRTRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
INGRPOLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
INGRSACCHARIN SODIUM (UNII: SB8ZUX40TY)  
INGRSORBITOL (UNII: 506T60A25R)  
INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
INGRMANNITOL (UNII: 3OWL53L36A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12.6 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic07/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/22/2020
Labeler - Swiss Shine Beauty AG (480422958)
Establishment
NameAddressID/FEIBusiness Operations
System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH328825757manufacture(79763-004)
Establishment
NameAddressID/FEIBusiness Operations
Marvinpac SA482060329pack(79763-004)

Revised: 8/2021
Document Id: c9ee4e8d-d528-9960-e053-2995a90a29bc
Set id: ab0ef0ce-e6a8-2707-e053-2995a90aef43
Version: 2
Effective Time: 20210819
 
Swiss Shine Beauty AG