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Kids Flouride Rinse (Hy-Vee, Inc)

Available Formats

Dosage Form Package Information Links
RINSE .5 L in 1 BOTTLE, PLASTIC (42507-004-44) Label Information

Complete Kids Flouride Rinse Information

  • ACTIVE INGREDIENT

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

    Purpose
    Anticavity rinse

  • INDICATIONS & USAGE

    Use aids in the prevention of dental cavities

  • 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.

  • 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


  • 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
  • STORAGE AND HANDLING

    Other information store at room temperature

  • SPL UNCLASSIFIED SECTION

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

  • ADVERSE REACTIONS

    Distributed by Hy-Vee, Inc.
    West Des Moines, IA 50266
    Satisfaction Guaranteed
    Call 1-800-289-8343
    www.hy-vee.com

  • PRINCIPAL DISPLAY PANEL

    Sealed with printed neckband for your protection
    Hy-Vee
    Strong Cavity protection
    Kids
    FLUORIDE RINSE
    ANTI CAVITY FLUORIDE RINSE

    BODACIOUS BUBBLE GUM
    Compare to the active ingredient of Act
    ALCOHOL FREE
    IMPORTANT:
    Read directions for proper use
    18 FL OZ (532 mL)
    image of principal display panel


  • INGREDIENTS AND APPEARANCE
    KIDS FLOURIDE RINSE 
    sodium fluoride rinse
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-004
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE .05 kg  in 100 L
    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:42507-004-44 .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 09/11/2003
    Labeler - Hy-Vee, Inc (006925671)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture