FLUORIDE SOFT MINT- sodium monofluorophosphate paste, dentifrice 
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 Toothpaste Soft Mint

Active Ingredients

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

Purpose Anticavity

Use

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.

Use
Aids in the prevention of dental cavities.

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.

Directions

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 Information

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

651 N. Broad St., Middletown, DE 19709

vVARDIS

SWITZERLAND

EDELWEISS

WHITE AND PROTECT

FLUORIDE TOOTHPASTE

SOFT MINT

NET WT 2.3OZ (65 g)

65g Fluoride Toothpaste

FLUORIDE SOFT MINT 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79763-003
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79763-003-0165 g in 1 TUBE; Type 0: Not a Combination Product07/22/2020
2NDC:79763-003-026.5 g in 1 TUBE; Type 0: Not a Combination Product07/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/22/2020
Labeler - Swiss Shine Beauty AG (480422958)
Establishment
NameAddressID/FEIBusiness Operations
System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH328825757manufacture(79763-003)
Establishment
NameAddressID/FEIBusiness Operations
Marvinpac SA482060329pack(79763-003)

Revised: 8/2021
Document Id: c9ed6374-1f64-d74d-e053-2995a90a0509
Set id: ab0c542c-1afb-0707-e053-2995a90a5eb4
Version: 3
Effective Time: 20210819
 
Swiss Shine Beauty AG