Label: ANTISEPTIC- cetylpyridinium chloride rinse

  • NDC Code(s): 49035-299-12, 49035-299-86
  • Packager: Wal-Mart Stores, Inc
  • 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 23, 2022

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 only

  • 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.
  • 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 yearsof 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

  • Questions

    Call 1-888-287-1915

  • SPL UNCLASSIFIED SECTION

    Alcohol Free Multi-Action Antiseptic Oral Rinse

    Sealed with printed Neckband for your protection

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

    Statisfaction guaranteed. For questions or comments please call 1-888-287-1915.

    Distributed by Wal-Mart Stores. INC

    Bentonville AR72716

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

  • principal display panel

    Equate

    Compare to Crest Pro-Health Rinse Multi-Protection Active Ingredient

    Alcohol Free Multi-Action Oral Rinse

    Antigingivitis/Antiplaque

    2X/Day Protection

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

    Zesty Mint

    Use morning & night for better oral hygiene

    1 L (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-299
    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:49035-299-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/22/2008
    2NDC:49035-299-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/22/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/22/2008
    Labeler - Wal-Mart Stores, Inc (051957769)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(49035-299)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(49035-299)