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Kids Flouride Rinse (Army + Air Force Exchange Service)

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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


  • Adverse reactions

    *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

    004.002/004AE


  • Principal Display Panel

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

    exchange select

    KIDS

    ANTICAVITY FLUORIDE RINSE

    ALCOHOL FREE

    • Strong cavity protection
    • Helps strengthen teeth
    • Freshens Breath

    BUBBLE GUM FLAVOR

    IMPORTANT: read directions for proper use.

    quality value

    18 FL OZ (532 mL)

    image description


  • 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)  
    EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    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)  
    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)