Dental Kit Strong Mint

Active Ingredients Purpose

sodium monofluorophosphate 0.88%

(0.115% W/W fluoride Ion) Anticavity

Use

Aids in the prevention of dental cavities

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.

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.

Adults and children 2 years of age and older:Brush teeth thoroughly, preferable 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

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

Switzerland

Dental Kit by VVARDIS

One Toothbrush

One Fluoride toothpaste

Strong Mint

NET. WT. 0.2 OZ (6.5g)

Dental Kit Strong Mint

DENTAL KIT STRONG MINT
sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82615-003

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82615-003-01	1 in 1 KIT; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)	03/04/2022

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	8.5 g
Part 2		1

Part 1 of 2

SRONG MINT FLUORIDE
sodium monofluorophosphate gel

Product Information
Item Code (Source)	NDC:82615-004
Route of Administration	DENTAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82615-004-01	6.5 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	03/05/2022

Part 2 of 2

TOOTHBRUSH
toothbrush, manual not applicable

Product Information
Route of Administration	DENTAL

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Exempt device	EFW	03/05/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	03/04/2022

Labeler - vVardis AG (480487038)