FLUORIDE STRONG MINT- sodium monofluorophosphate paste

Fluoride Strong Mint by

Drug Labeling and Warnings

Fluoride Strong 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 Purpose

sodium monofluorophosphate 0.88% Anticavity

(0.115% W/V fluoride)

PURPOSE

Use

• Aids in the prevention of dental cavities

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age.

INDICATIONS & USAGE

If more than used for brushing 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.

DOSAGE & ADMINISTRATION

Directions

• 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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

vVardis Switzerland

edelwiess

white and protect

Fluoride Toothpaste Strong Mint

NET WT 2.3 OZ (65 g)

INGREDIENTS AND APPEARANCE

FLUORIDE STRONG MINT 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79763-007
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
ZINC LACTATE (UNII: 2GXR25858Y)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM COCO-SULFATE (UNII: 3599J29ANH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CALCIUM CARBONATE (UNII: H0G9379FGK)
XYLITOL (UNII: VCQ006KQ1E)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWERING TOP (UNII: QQC1AK06RK)
SODIUM BENZOATE (UNII: OJ245FE5EU)
RHODODENDRON FERRUGINEUM WHOLE (UNII: FO6B1S7BZU)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79763-007-01	65 g in 1 TUBE; Type 0: Not a Combination Product	10/14/2020
2	NDC: 79763-007-02	6.5 g in 1 TUBE; Type 0: Not a Combination Product	01/17/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/14/2020

Labeler - Swiss Shine Beauty AG (480422958)

Establishment
Name	Address	ID/FEI	Business Operations
System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH		328825757	manufacture(79763-007)

Establishment
Name	Address	ID/FEI	Business Operations
Marvinpac SA		482060329	pack(79763-007)