DENTAL KIT SOFT MINT- sodium monofluorophosphate 
vVARDIS 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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Dental Kit Soft Mint

Active Ingredients Purpose

Sodium monofluorophosphate 0.88% (0.115% W/V fluoride Ion) Anticavity

Use - Aids in the prevention of dental cavities.

Keep out of reach of children under 6 years age.

Use
Aids in the prevention of dental cavities.

Keep our 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 doctor.

Other Information

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

651 N. Broad St., Middletown, DE 19709

Inactive Ingredients

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

vVARDIS

Switzerland

Dental Kit by VVARDIS

One Toothbrush

One Fluoride toothpaste

Soft Mint

NET. WT. 0.2 OZ (6.5g)

dental kit soft

DENTAL KIT SOFT MINT 
sodium monofluorophosphate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82615-001
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82615-001-011 in 1 KIT; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)03/07/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 6.5 g
Part 2
Part 1 of 2
SOFT MINT FLUORIDE 
sodium monofluorophosphate gel
Product Information
Item Code (Source)NDC:82615-002
Route of AdministrationDENTAL
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
XANTHAN GUM (UNII: TTV12P4NEE)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
XYLITOL (UNII: VCQ006KQ1E)  
SODIUM COCO-SULFATE (UNII: 3599J29ANH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
LEONTOPODIUM ALPINUM FLOWERING TOP (UNII: QQC1AK06RK)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
GLYCERIN (UNII: PDC6A3C0OX)  
RHODODENDRON FERRUGINEUM WHOLE (UNII: FO6B1S7BZU)  
LACTIC ACID (UNII: 33X04XA5AT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82615-002-016.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/07/2022
Part 2 of 2
TOOTHBRUSH 
toothbrush, manual not applicable
Product Information
Route of AdministrationDENTAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Exempt deviceEFW03/07/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/07/2022
Labeler - vVARDIS AG (480487038)

Revised: 3/2022
Document Id: d9a63ffa-4175-76f0-e053-2a95a90ab7c3
Set id: d9a63ffa-4174-76f0-e053-2a95a90ab7c3
Version: 1
Effective Time: 20220307
 
vVARDIS AG