Label: ANTISEPTIC- cetylpyridinium chloride rinse

  • NDC Code(s): 55301-299-86
  • Packager: Your Military Exchanges
  • 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 24, 2022

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

View All Sections
  • 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 dentis if

    • gingivitis, bleeding, or redness persists for more than 2 weeks
    • you have painful or swollen gums, puss from the gum line, loose teeth or increaded spacing between the teeth.  These may be signs or symptoms 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

    SEALED WITH PRINTED NECK BAND FOR YOUR PROTECTION

    MULTI ACTION ANTISEPTIC RINSE

    MOUTHRINSE

    ANTIGINGIVITIS/ANTIPLAQUE

    For better oral hygiene and fresher breath

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

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

    SATISFACTION GUARANTEED OR YOUR MONEY BACK

    Manufactured For Your Military Exchanges

    By: Vi-Jon

    8515 Page Avenue, St. Louis, MO 63114

  • principal display panel

    ALCOHOL FREE

    Compare To The Active Ingredient of Crest Pro-Health Rinse*

    exchange select

    MULTI ACTION ANTISEPTIC RINSE

    MOUTHRINSE

    ANTIGINGIVITIS/ANTIPLAQUE

    Zesty Mint

    • Kills germs
    • Helps prevent plaque
    • Helps prevent gingivitis
    • Helps keep teeth feeling clean
    • Freshens breath
    • No burn of alcohol

    1 L (33.8 FL OZ)

    Quality Value

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55301-299
    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:55301-299-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/28/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/28/2010
    Labeler - Your Military Exchanges (001695568)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55301-299)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55301-299)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!