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

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 June 10, 2021

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

  • Active ingredient

    Cetylpyridinium chloride 0.07%

  • Purpose

    Antigingivitis, Antiplaque

  • Use

    helps control plaque that leads to gingivitis

  • Warnings

    for this product

  • 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 gum line, loose teeth or increased spacing between the teeth. These may be signs or smptoms of periodontitis, a serious form of gum disease
  • 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.

  • 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
  • Other information

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

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

  • SPL UNCLASSIFIED SECTION

    For better oral hygiene and fresher breath.

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

    DISTRIBUTED BY

    DEMOULAS SUPER MARKETS, INC.

    875 EAST STREET

    TEWKSBURY, MA 01876

  • principal display panel

    MORE FOR YOUR DOLLAR

    MARKET BASKET

    Sealed with printed neckband for your protection

    Compare to active ingredient in Crest Pro-Health Rinse

    Mulit-Action Alcohol-Free Antiseptic Oral Rinse with CPC

    Antigingivitis/Antiplaque

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

    Zesty Mint

    1 L (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISPETIC 
    cetylpyridinium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-299
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53942-299-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/21/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/21/2012
    Labeler - Demoulas Super Markets (007869647)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(53942-299)