Label: HEALTH- cetylpyridinium chloride mouthwash

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 2, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Tamper Evident Statement

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION.

  • Claims

    KILLS GERMS THAT CAUSE

    • Plaque
    • Gingivitis
    • Bad Breath
  • Disclaimer

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

  • Active ingredients

    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, 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 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
  • 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

  • Disclaimer

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

    DISTRIBUTED BY

    Old East Main

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

    100% Satisfaction Guaranteed (888)309-9030

  • Adverse Reaction

    DISTRIBUTED BY Old East Main Co.

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

    100% Satisfaction Guaranteed (888)309-9030

  • Principal display panel

    DG® health

    Compare to Crest® Pro-Health® Multi-Protection Refreshing Clean Mint*

    ALCOHOL-FREE

    ANTISPETIC

    ORAL RINSE

    Antigingivitis / Antiplaque

    Mouth Rinse

    VIVID MINT

    MULTI-ACTION

    • Helps Prevent plaque
    • Helps Prevent gingivitis
    • Helps keep teeth feeling clean
    • Freshens breath
    • No burn of alcohol

    33.8 FL OZ (1.05 QT) 1 L

    image description

  • Principal display panel

    Since 1903

    Rexall

    Alcohol-Free

    Antiseptic

    Oral Rinse

    Antigingivitis/Antiplaque

    MULTI-ACTION

    • Kills germs commonly associated with gingivitis
    • Helps prevent plaque
    • No burn of alcohol

    VIVID MINT FLAVOR

    1 L (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    HEALTH 
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-299
    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:55910-299-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/21/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)07/21/2008
    Labeler - Old East Main. Co (068331990)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55910-299)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55910-299)
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

More Info on this Drug

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