Label: ANTISPETIC- cetylpyridinium chloride liquid 

  • NDC Code(s): 53942-299-86
  • Packager: Demoulas Super Markets
  • 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 12/12

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

  • claims

    For better oral hygiene and fresher breath.

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  • Active ingredient

    Active ingredient

    Cetylpyridinium chloride 0.07%

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  • Purpose

    Purpose

    Antigingivitis, Antiplaque

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  • Use

    Use hlep control plaque that leads to gingivitis

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  • Warnings

    Warnings

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  • Stop use

    Stop use and ask a dentist if

    • gingivitis, gleeding or redness persists for more than 2 weeks
    • you have painful or swollen gums, pus from the fum line, loose teeth or increased spacing between the teeth. These may be signs or smptoms 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 seconds 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, blue1

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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 Reaction

    DISTRIBUTED BY

    DEMOULAS SUPER MARKETS, INC.

    875 EAST STREET

    TEWKSBURY, MA 01876

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  • Principal Display Panel

    More For Your Money

    MARKET BASKET

    Sealed with printed neckband for your protection

    Compare to active ingredient in Crest PKILLS ro-Heal Rinse

    Multi-Action

    Alcohol-Free

    ANTISEPTIC

    ORAL RINSE

    with CPC

    Antigivitis/Antiplaque

    • KILLS GERMS
    • HELPS PREVET PLAQUE
    • HELPS PREVENT GINGIVITIS
    • HELPS KEEP TEETH FEELING CLEAN
    • FRESHENS BREATH
    • NO BURN ALCOHOL

    Zesty Mint

    1 L (33.8 FL OZ)

    image description

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  • INGREDIENTS AND APPEARANCE
    ANTISPETIC 
    cetylpyridinium chloride liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53942-299
    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:53942-299-86 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 02/21/2012
    Labeler - Demoulas Super Markets (007869647)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(53942-299)
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