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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 INGREDIENT

    Mouthwash

    Active ingredients

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

  • ACTIVE INGREDIENT

    Toothpaste

    Active Ingredients

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

  • PURPOSE

    Use

    Aids in the prevention of dental cavities.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Supervise children as necessary until capable of using without supervison.

  • 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 without 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 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

  • INACTIVE INGREDIENT

    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

  • PRINCIPAL DISPLAY PANEL

    VVardis Set Strong Mint

    vVardis set strong v1 back

    vVardis set stong v1 front

  • INGREDIENTS AND APPEARANCE
    VVARDIS SET STRONG MINT 
    sodium monofluorophosphate, sodium fluoride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79763-008
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79763-008-011 in 1 KIT10/14/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 100 mL  in 100 
    Part 21 TUBE 65 g  in 65 
    Part 31 BOTTLE, WITH APPLICATOR 2.6 g  in 100 
    Part 1 of 3
    PURE WHITENING FLUORIDE MOUTHWASH STRONG MINT 
    sodium fluoride liquid
    Product Information
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1100 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 finalpart35610/15/2020
    Part 2 of 3
    FLUORIDE STRONG MINT 
    sodium monofluorophosphate gel
    Product Information
    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
    SODIUM COCO-SULFATE (UNII: 3599J29ANH)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    RHODODENDRON FERRUGINEUM WHOLE (UNII: FO6B1S7BZU)  
    LEONTOPODIUM ALPINUM FLOWERING TOP (UNII: QQC1AK06RK)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    165 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 finalpart35510/15/2020
    Part 3 of 3
    INSTANT BRIGHT AND WHITE CONCENTRATE FOR TEETH 
    other oral hygiene products gel
    Product Information
    Route of AdministrationDENTAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRSORBITOL (UNII: 506T60A25R)  
    INGRHYDRATED SILICA (UNII: Y6O7T4G8P9)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRMANNITOL (UNII: 3OWL53L36A)  
    INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
    INGRPOLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    INGRTRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    INGRCALCIUM CARBONATE (UNII: H0G9379FGK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12.6 g in 1 BOTTLE, WITH APPLICATOR; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic10/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35610/14/2020
    Labeler - Swiss Shine Beauty AG (480422958)
    Establishment
    NameAddressID/FEIBusiness Operations
    System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH328825757manufacture(79763-008)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marvinpac SA482060329pack(79763-008)
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