VVARDIS SET STRONG MINT- sodium monofluorophosphate, sodium fluoride 
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 STRONG MINT

Mouthwash

Active ingredients

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

Toothpaste

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.

Supervise children as necessary until capable of using without supervison.

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

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.

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, 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 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

VVardis Set Strong Mint

vVardis set strong v1 back

vVardis set stong v1 front

VVARDIS SET STRONG MINT 
sodium monofluorophosphate, sodium fluoride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79763-008
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79763-008-011 in 1 KIT10/14/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 100 mL  in 100 
Part 21 TUBE 65 g  in 65 
Part 31 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 AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1100 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 finalpart35610/15/2020
Part 2 of 3
FLUORIDE STRONG MINT 
sodium monofluorophosphate gel
Product Information
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
165 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 finalpart35510/15/2020
Part 3 of 3
INSTANT BRIGHT AND WHITE CONCENTRATE FOR TEETH 
other oral hygiene products gel
Product Information
Route of AdministrationDENTAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRSORBITOL (UNII: 506T60A25R)  
INGRHYDRATED SILICA (UNII: Y6O7T4G8P9)  
INGRWATER (UNII: 059QF0KO0R)  
INGRMANNITOL (UNII: 3OWL53L36A)  
INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
INGRPOLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
INGRTRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
INGRCALCIUM CARBONATE (UNII: H0G9379FGK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12.6 g in 1 BOTTLE, WITH APPLICATOR; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic10/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35610/14/2020
Labeler - Swiss Shine Beauty AG (480422958)
Establishment
NameAddressID/FEIBusiness Operations
System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH328825757manufacture(79763-008)
Establishment
NameAddressID/FEIBusiness Operations
Marvinpac SA482060329pack(79763-008)

Revised: 8/2021
Document Id: c9ee4590-eca7-3188-e053-2a95a90afbc2
Set id: b1aa063c-cf71-487b-e053-2995a90af818
Version: 2
Effective Time: 20210819
 
Swiss Shine Beauty AG