Label: KIDS FLOURIDE RINSE- sodium fluoride rinse

  • NDC Code(s): 55301-004-44
  • Packager: Your Military Exchanges
  • 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 21, 2015

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

  • TEP

    SEALED WITH PRINTED NACK BAND FOR YOUR PROTECTION

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  • Active ingredient

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

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  • Purpose

    Anticavity rinse

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  • Use

    aids in the prevention of dental cavities

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  • Warnings

    For this product

    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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  • Directions

    • adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpasted
    • remove cap
    • pour 10 millilters (10 mL mark on inside of cap); do not fill above 10 mL mark
    • vigourously 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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  • Other information

    • store at room temperature

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  • 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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  • disclaimer

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

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  • Adverse Reaction

    SATISFACTION GUARANTEED OR YOUR MONEY BACK

    Manufactured For Your Military Exchanges

    By: Vi-Jon, 8515 Page Avenue

    St. Louis, MO 63114

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  • Principal Display

    Compare to the

    active ingedient 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

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  • 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 ANHYDROUS (UNII: 8U5D034955)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    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
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 02/09/2011
    Labeler - Your Military Exchanges (001695568)
    Registrant - Vi-Jon (150931459)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 150931459 manufacture(55301-004)
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