Label: ANTISEPTIC- cetylpyridinium chloride mouthwash

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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.

  • Warning

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

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  • Claims

    HyVee

    Antiseptic

    Mouth Rinse

    Alcohol-Free

    ´╗┐For better oral hygiene and fresher breath

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  • Active Ingredients

    Active ingrdients

    Cetylpyridinium chloride 0.07%

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  • Purpose

    Purpose

    Antigingivitis, Antiplaque

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  • Use

    Use helps control plaque that leads to gingivitis

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  • Warnings

    Warnings

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  • Stop use section

    Stop use and ask a dentist if

    • gingivitis, bleeding or redness persists fr more than 2 weeks
    • you have painful or swollen gums, pus from the gum line, loose teth or increased spacing between the teeth. Thee may be signs or symptoms of periodontitis, a serious form of gum disease.
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  • Keep out of reach of children

    Keep out of reach of children under 6 years of age. If more than used for rnsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    Directions

    • adults and children 6 years + older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
    • do not swallow
    • children 6 yeard to under 12 years of age: supervise use
    • when used after brushing, rinse mouth with water first
    • children under 6 years of age: do not use
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  • other informatin

    Other information

    • this rinse is not intended to replace brushing or flossing
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  • Inactive ingredients

    Inactive ingredients water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, methylparaben, sucralose, propylparaben, blue 1

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  • Disclaimer

    This product is not manufactured or distributed by Procter + Gamble, distributor of Crest Pro-Health Rinse

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  • Adverse reactions

    DISTRIBUTED BY HY-VEE, INC., WEST DES MOINES, IA 50266

    SATISFACTION GUARANTEED, CALL 1-800-289-8343

    www.hy-vee.com

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  • Principal Display Panel

    Hy-Vee

    Antiseptic

    MOUTH RINSE

    ALCOHOL-FREE

    Zesty Mint

    Antigingivitis/Antiplaque

    • Kills germs
    • Helps prevent
    • Helps prevent gingivitis
    • Helps keep teeth feeling clean
    • Freshen breath
    • 2.2ex0em2.2ex0emNo burn of alcohol

    15.390625px15.390625pxCompare to active ingrediet in Crest Pro-Health rinse

    15.390625px15.390625px1 L (33.8 FL OZ)

    15.390625px15.390625pximage description

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  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    cetylpyridinium chloride 0.07% mouthwash
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42507-299
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE 0.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    GLYCERIN  
    POLOXAMER 188  
    SACCHARIN SODIUM  
    PROPYLENE GLYCOL  
    METHYLPARABEN  
    SUCRALOSE  
    PROPYLPARABEN  
    FD&C BLUE NO. 1  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42507-299-86 1000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 02/18/2010
    Labeler - Hy-Vee, Inc (006925671)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(42507-299)
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