Label: ANTICAVITY- sodium fluoride rinse

  • 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 01/13

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

  • Active ingredient

    Active ingredient

    Sodium fluoride 0.055% (0.02% w/v fluoride ion)

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  • Purpose

    Purpose

    Anticavity rinse

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  • Use

    Use aids in the prevention of dental cavities

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  • Warnings

    Warnings

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  • Keep out of reach of children

    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

    Directions

    • adults and children 6 years of age and older: use once a day after brushing your teeth with toothpaste
    • remove cap
    • pour 10 mililiters (10 mL mark on inside of cap); do not fill above thr 10 mL mark
    • vigorously swish 10 mililiters 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

    Other information

    • store at room temperature
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  • Inactive ingredients

    Inactive ingredients benzyl alcohol, calcium disodium EDTA, cetylpridinium 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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  • Adverse Reactions

    Comments or Questions?

    800-632-6900 or www. kroger.com

    DISTRIBUTED BY

    THE KORGER CO.

    CINCINNATI, OH 45202

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  • Principal Display Panel

    Sealed with printed neckband for your protection.

    IMPORTANT: read directions for proper use

    Kroger

    Quality Guaranteed

    KIDS

    Anticavity

    Fluoride Rinse

    strong cavity protection

    alcohol free

    helps strengthen teeth

    helps prevent cavities

    16.0 FL OZ

    (500 mL)

    bubblegum

    Flavor

    image description

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  • INGREDIENTS AND APPEARANCE
    ANTICAVITY 
    sodium fluoride rinse
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:30142-004
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 10.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL  
    EDETATE CALCIUM DISODIUM ANHYDROUS  
    CETYLPYRIDINIUM CHLORIDE  
    EDETATE DISODIUM  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    POLOXAMER 407  
    POLYSORBATE 80  
    PROPYLENE GLYCOL  
    D&C RED NO. 33  
    SODIUM BENZOATE  
    SODIUM PHOSPHATE  
    SACCHARIN SODIUM  
    SORBITOL  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30142-004-77 500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 01/18/2013
    Labeler - Kroger Co (006999528)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(30142-004)
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