Label: VVARDIS SET SOFT MINT- sodium fluoride, sodium monofluorophosphate kit

  • 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 19, 2021

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  • Active Ingredients

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

    Purpose Anticavity

  • Active Ingredients

    Sodium monofluorophosphate 0.88% (0.115% W/V flouride ion)

    Purpose Anticavity

  • Use

    Aids in the prevention of dental cavities.

  • KEEP OUT OF REACH OF CHILDREN

    Warnings Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • INDICATIONS & USAGE

    Supervise children as necessary until capable of using without supervison.

    Children under 2 years of age: Consult a dentist or doctor.

  • INDICATIONS & USAGE

    Supervise children as necessary until capable of using without supervision.

    Children under 6 years of age: Consult a dentist or doctor.

  • WARNINGS

    Warnings Keep out of reach of children. If more than used for rinsing is accidently swallowed, get medical help or contact a Poison Control Center right away.

  • WARNINGS

    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

    • 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 milliliters of rinse between your teeth for 1 minute and then spit out.
    • Do not swallow the rinse.
    • Do not eat or drink for 30 minutes after rinsing.
    • Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
    • Supervise children as necessary until capable of using wihtout supervision.
    • Children under 6 years of age: Consult a dentist or doctor.
  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably 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 supervison.
    • Children under 2 years of age: consult a dentist or doctor.
  • Inactive Ingredients

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

  • Inactive Ingredients

    water, hydrated silica, hydrogenated starch hydrolysate, glycerin, hydroxyapatite, xylitol, sodium coco-sulfate, calcium carbonate, flavor, xanthan gum, citric acid, potassium 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

    Tamper evident: Do not use if safety seal is broken or missing.

  • PRINCIPAL DISPLAY PANEL

    WEISSBAD

    FRESH AND PROTECT

    PURE WHITENING

    FLUORIDE MOUTHWASH

    SOFT MINT

    100 ml e /3.4 FL OZ

    EDELWEISS
    WHITE AND PROTECT
    FLUORIDE TOOTHPASTE
    SOFT MINT


    NET WT 2.3 OZ (65 g)

    VVardis Soft mint back

    Soft mint Set front panel

  • INGREDIENTS AND APPEARANCE
    VVARDIS SET SOFT MINT 
    sodium fluoride, sodium monofluorophosphate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79763-004
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79763-004-011 in 1 KIT; Type 1: Convenience Kit of Co-Package07/22/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 100 mL
    Part 21 TUBE 65 g
    Part 31 BOTTLE, WITH APPLICATOR 2.6 g
    Part 1 of 3
    FLOURIDE MOUTHWASH SOFT MINT 
    sodium flouride mouthwash
    Product Information
    Item Code (Source)NDC:79763-005
    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
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79763-005-01100 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/22/2020
    Part 2 of 3
    FLOURIDE SOFT MINT 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Item Code (Source)NDC:79763-006
    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
    XYLITOL (UNII: VCQ006KQ1E)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    LEONTOPODIUM ALPINUM FLOWERING TOP (UNII: QQC1AK06RK)  
    RHODODENDRON FERRUGINEUM WHOLE (UNII: FO6B1S7BZU)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    WATER (UNII: 059QF0KO0R)  
    HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM COCO-SULFATE (UNII: 3599J29ANH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79763-006-0165 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35507/22/2020
    Part 3 of 3
    INSTANT BRIGHT AND WHITE CONCENTRATE 
    other oral hygiene products gel
    Product Information
    Route of AdministrationORAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRCALCIUM CARBONATE (UNII: H0G9379FGK)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRCALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRHYDRATED SILICA (UNII: Y6O7T4G8P9)  
    INGRCALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    INGRFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    INGRTRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    INGRPOLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    INGRSACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    INGRSORBITOL (UNII: 506T60A25R)  
    INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
    INGRMANNITOL (UNII: 3OWL53L36A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12.6 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic07/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/22/2020
    Labeler - Swiss Shine Beauty AG (480422958)
    Establishment
    NameAddressID/FEIBusiness Operations
    System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH328825757manufacture(79763-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marvinpac SA482060329pack(79763-004)
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