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Kids Flouride Rinse (Army + Air Force Exchange Service)

Available Formats

Dosage Form Package Information Links
RINSE .5 L in 1 BOTTLE, PLASTIC (55301-004-44) Label Information

Complete Kids Flouride Rinse Information

  • Active ingredient

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

    Purpose

    Anticavity rinse


  • Use

    aids in the prevention of dental cavities


  • WARNINGS

    Warnings

    Keep out of reach of children.

    If more than used for rinsing is accidentally 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 milliters (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


  • Other information

    store at room temperature


  • 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


  • SPL UNCLASSIFIED SECTION

    *This is not manufactured or distributed by Chattem, Inc., distributor of Act

    SATISFACTION GUARANTEED OR YOUR MONEY BACK
    Manufactured for Your Military Exchanges
    By: Vi-Jon
    8515 Page Ave
    St. Louis, MO 83114


  • PRINCIPAL DISPLAY PANEL

    exchange select
    Kids
    ANTICAVITY FLUORIDE RINSE BUBBLE GUM FLAVOR

    Compare to the Active ingredient of Act Anticavity Fluoride Rinse*
    Strong cavity protection
    Helps strengthen teeth
    Helps prevent cavities
    Alcohol free
    IMPORTANT: read directions for proper use
    Sealed with printed neckband for your protection
    18 FL OZ (532 mL)

    image of principal display panel

    004.001/004AE


  • INGREDIENTS AND APPEARANCE
    KIDS FLOURIDE RINSE 
    sodium fluoride rinse
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-004
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55301-004-44 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/09/2011
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 02/09/2011
    Labeler - Army + Air Force Exchange Service (001695568)
    Registrant - Vi-Jon (150931459)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 150931459 manufacture(55301-004)