FLUORIDE SOFT MINT- sodium monofluorophosphate paste, dentifrice

Fluoride Soft Mint by

Drug Labeling and Warnings

Fluoride 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 INGREDIENT

Active Ingredients

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

Purpose Anticavity

PURPOSE

Use

• Aids in the prevention of dental cavities.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years age.

If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Use
Aids in the prevention of dental cavities.

WARNINGS

Warnings

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.

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

INACTIVE INGREDIENT

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

OTHER SAFETY INFORMATION

Other Information

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

651 N. Broad St., Middletown, DE 19709

PRINCIPAL DISPLAY PANEL

vVARDIS

SWITZERLAND

EDELWEISS

WHITE AND PROTECT

FLUORIDE TOOTHPASTE

SOFT MINT

NET WT 2.3OZ (65 g)

INGREDIENTS AND APPEARANCE

FLUORIDE SOFT MINT 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79763-003
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
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM COCO-SULFATE (UNII: 3599J29ANH)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LACTIC ACID (UNII: 33X04XA5AT)
CALCIUM CARBONATE (UNII: H0G9379FGK)
WATER (UNII: 059QF0KO0R)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LEONTOPODIUM ALPINUM FLOWERING TOP (UNII: QQC1AK06RK)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
RHODODENDRON FERRUGINEUM WHOLE (UNII: FO6B1S7BZU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79763-003-01	65 g in 1 TUBE; Type 0: Not a Combination Product	07/22/2020
2	NDC: 79763-003-02	6.5 g in 1 TUBE; Type 0: Not a Combination Product	07/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	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(79763-003)

Establishment
Name	Address	ID/FEI	Business Operations
Marvinpac SA		482060329	pack(79763-003)