Label: HEALTH- 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 02/13

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

  • Claims

    Oral Health

    Mouth

    Rinse

    For better oral hygiene

    and fresher breath

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  • safety seal

    Sealed with printed neckband for your protection

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  • Active ingredients

    Active ingredient

    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 and ask a dentist if

    Stop use and ask a dentist if

    • gingivitis, bleeding, or redness persists for more than 2 weeks
    • you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between te teeth. These may be sings 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 rinsing 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 secnds with 20 mL (4 teaspoonfuls) twice a day
    • do not swallow
    • children 6 years 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 information

    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

    DOLGENCORP, LLC

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

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  • Principal display panel

    DGhealth

    Oral Health

    MOUTH
    RINSE

    Zesty Mint Flavor

    Compare to active ingredient in Crest Pro-Health Rinse

    • Antigingivitis/Antiplaque
    • Alcohol-Free
    • Kills germs that cause bad breath

    1 L (33.8 FL OZ)

    image description

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  • INGREDIENTS AND APPEARANCE
    HEALTH 
    cetylpyridinium chloride mouthwash
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55910-299
    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  
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    Does not contain FD&C BLUE NO. 1 0 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55910-299-86 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 07/21/2008
    Labeler - DOLGENCORP, LLC (068331990)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(55910-299)
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