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 06/15

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

  • Claims

    Sealed With Printed Neckband For Your Protection

    MULTI-ACTION

    ALCOHOL-FREE

    ORAL

    RINSE

    Antigingivitis/Antiplaque

    Use 2X/Day for

    better oral hygiene

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  • Active ingredients

    Cetylpyridinium chloride 0.07%

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  • purpose

    Antigingivitis/Antiplaque

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  • Use

    ´╗┐helps control plaque that leads to gingivitis

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  • Warnings

    For this product

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  • 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 the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
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  • 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

    • 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

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

    water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

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  • Disclaimer

    This rinse ay cause temporary staining to the surface of teeth.  This is not harmful and adequate brushing may prevent it occurence.

    This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Multi-Protection Alcohol Free Rinse- Refreshing Clean Mint

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  • Adverse Reactions

    DISTRIBUTED BY

    DOLGENCORP, LLC

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

    100% Satisfaction Guaranteed (888)309-9030

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  • Principal Display Panel

    DG health

    Compare to Crest Pro-Health

    Multi-Protection Alcohol Free rinse

    Use

    2X/Day

    for better oral hygiene

    MULTI-ACTION

    ALCOHOL-FREE

    ORAL RINSE

    Antigingivitis/Antiplaque

    FRESH MINTY FLAVOR

    MULTIPLE BENEFITS

    • Kills Germs
    • Freshens Breath
    • Helps Prevent Plaque & Gingivitis
    • Helps Keep Teeth Feeling Clean

    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 Item Code (Source) NDC:55910-299
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 0.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55910-299-86 1000 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 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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