KIDS ANTICAVITY MOUTHWASH [VI JON]

KIDS ANTICAVITY MOUTHWASH [VI JON]
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NDC 0869-0004-44
Set ID 36b98565-484f-4864-aebb-c488abab88e5
Category HUMAN OTC DRUG LABEL
Packager Vi Jon, LLC
Generic Name
Product Class
Product Number
Application Number PART355
  • Active ingredient

    Sodium fluoride 0.05% (0.02% w/v fluoride ion)

  • Purpose

    Anticavity rinse

  • Use

    aids in the prevention of dental cavities

  • Warnings

    for this product

  • Keep out of reach of children.

    If more than used for rinsing is accidentaly swallowed, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    •adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste.

    •remove cap

    •pour 10 milliliters (10 mL mark on inside of cap):do not fill above the 10 mL mark

    •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

  • Inactive ingredients

    benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

  • claims

    Sealed With Printed neckband For Your Protection

    "The ADA Council on Scientific Affairs' Acceptance of Swan Anticavity Fluoride Rinse is based on its finding that the product is effective in helping to prevent and reduct tooth decay, when used as directed"

    *This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Rinse.

    Distributed by: Vi-Jon, LLC  One Swan Drive, Smyrna, TN 37167

    004.002/004AE

  • principal display panel

    Sealed With Printed Neckband For Your Protection

    SWAN

    kids

    ANTICAVITY

    ALCOHOL FREE

    FLUORIDE RINSE

    bubble gum

    FLAVOR

    Strong Cavity Protection

    Compare to the active ingredient of Bubblegum Blowout Act Anticavity Fluoride Rinse

    IMPORTANT:READ DIRECTIONS FOR PROPER USE

    ADA

    Accepted

    American

    Dental

    Association

    18 FL OZ (532 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    KIDS ANTICAVITY 
    kids anticavity mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DISODIUM DIHYDROGEN HYPOPHOSPHATE (UNII: MR6TW8IQ9X)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUM (Bubble Gum Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0869-0004-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/06/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35504/06/2004
    Labeler - Vi Jon, LLC (790752542)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(0869-0004)

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