FLUORIDE STRONG MINT- sodium monofluorophosphate paste 
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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Fluoride Strong Mint

Active Ingredients Purpose

sodium monofluorophosphate 0.88% Anticavity

(0.115% W/V fluoride)

Use

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.

Directions

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

edelwiess

white and protect

Fluoride Toothpaste Strong Mint

NET WT 2.3 OZ (65 g)

vVardis Edelweiss strong mint

FLUORIDE STRONG MINT 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79763-007
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79763-007-0165 g in 1 TUBE; Type 0: Not a Combination Product10/14/2020
2NDC:79763-007-026.5 g in 1 TUBE; Type 0: Not a Combination Product01/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/14/2020
Labeler - Swiss Shine Beauty AG (480422958)
Establishment
NameAddressID/FEIBusiness Operations
System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH328825757manufacture(79763-007)
Establishment
NameAddressID/FEIBusiness Operations
Marvinpac SA482060329pack(79763-007)

Revised: 1/2022
Document Id: d60811f7-b1dc-719b-e053-2a95a90ab2fc
Set id: b1a5b43b-d5ea-3980-e053-2995a90a3b01
Version: 3
Effective Time: 20220120
 
Swiss Shine Beauty AG