FLOURIDE MOUTHWASH STRONG MINT- sodium fluoride mouthwash 
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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Flouride Mouthwash Strong Mint

Active Ingredients Purpose

Sodium Fluoride 0.05 (0.02% W/V fluoride ion) Anticavity

Use

Keep out of reach of children

if more than used for rinsing is accidenttally swallowed, get medical help or contact a Poison Control Center right away.

Do not swallow the rinse

Warnings

Keep out of reach of children

if more than used for rinsing is accidenttally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

water, glycerin, propylene glycol, xylitol, peg-40 hydrogenated castor oil, flavor, sodium citrate,zinc lactate, poloxamer 407, chlorhexidine digluconate, citric acid, hydrochloric acid, oligopeptide-104, sodium hydroxide

vVardis

Switzerland

WEISSBAD

FRESH AND PROTECT

PURE WHITENING

FLUORIDE MOUTHWASH

STRONG MINT

IMPORTANT: READ DIRECTIONS FOR PROPER USE

3.4 FL OZ / 100 ml

Fluoride Mouthwash Strong Mint

FLOURIDE MOUTHWASH STRONG MINT 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79763-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
XYLITOL (UNII: VCQ006KQ1E)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GLYCERIN (UNII: PDC6A3C0OX)  
ZINC LACTATE (UNII: 2GXR25858Y)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79763-001-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/21/2020
Labeler - Swiss Shine Beauty AG (480422958)
Establishment
NameAddressID/FEIBusiness Operations
System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH328825757manufacture(79763-001)
Establishment
NameAddressID/FEIBusiness Operations
Marvinpac SA482060329pack(79763-001)

Revised: 8/2020
Document Id: abfd59e2-c20a-d771-e053-2a95a90ad785
Set id: aaf760fb-2e2c-4c9e-e053-2995a90a2a4e
Version: 2
Effective Time: 20200803
 
Swiss Shine Beauty AG