Label: KIDS FLOURIDE RINSE - sodium fluoride rinse 

  • NDC Code(s): 55301-004-44
  • Packager: Army + Air Force Exchange Service
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/11

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

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

    Purpose
    Anticavity rinse
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  • INDICATIONS & USAGE

    Use aids in the prevention of dental cavities
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  • WARNINGS

    Warning

    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.
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  • DOSAGE & ADMINISTRATION

    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

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  • STORAGE AND HANDLING

    Other information • store at room temperature
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  • INACTIVE INGREDIENT

    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
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  • SPL UNCLASSIFIED SECTION

    This is not manufactured or distributed by Chattem, Inc., distributor of Act
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  • ADVERSE REACTIONS

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

    exchange
    select
    Kids
    ANTICAVITY
    FLUORIDE RINSE
    BUBBLE GUM FLAVOR

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

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  • INGREDIENTS AND APPEARANCE
    KIDS FLOURIDE RINSE 
    sodium fluoride rinse
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55301-004
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE .05 kg  in 100 L
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL  
    CETYLPYRIDINIUM CHLORIDE  
    POLOXAMER 407  
    POLYSORBATE 80  
    PROPYLENE GLYCOL  
    SODIUM BENZOATE  
    SODIUM PHOSPHATE  
    SORBITOL  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55301-004-44 .5 L in 1 BOTTLE, PLASTIC
    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
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