Label: FLOURIDE MOUTHWASH STRONG MINT- sodium fluoride mouthwash

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated August 3, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients Purpose

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

  • PURPOSE

    Use

    • Aids in the prevention of dental cavities
  • KEEP OUT OF REACH OF CHILDREN

    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.

  • INDICATIONS & USAGE

    Do not swallow the rinse

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • Shake well before use
    • Adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste.
    • Vigorously swish 10 milliters of rinse between your teeth for 1 minute and then spit out.
    • Do not eat or drink for 30 minutesafter rinsing.
    • Instruct children under 12 year of age in good rinsing habits (to minimize swallowing).
    • Supervise children as necessary until capable of using without supervision.
    • Children under 6 years of age: consult a dentist or doctor.
  • INACTIVE INGREDIENT

    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

  • PRINCIPAL DISPLAY PANEL

    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

  • INGREDIENTS AND APPEARANCE
    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)