Label: HEALTH- cetylpyridinium chloride mouthwash

  • 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 28, 2022

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  • Claims

    Healthy

    Accents

    For Better Oral Hygiene

    and Fresher Breath

  • 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 & older: 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

    Healthy Accents

    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 it occurence.

    *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:DZA BRANDS, LLC

    2110 Executive Drive

    Salisbury, NC 28147

    For product questions or concerns,

    contact us at 1-866-322-2439

    Please include UPC number and code from the package

  • principal display panel

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    healthy accents multi-action alcohol free antiseptic oral rinse

    antigingivitis/antiplaque

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

    compare to the ingredients in Crest Pro-Health Multi-Protection Alcohol Free Rinse-Refreshing Clean Mint*

    1 L (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    HEALTH 
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-942
    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:55316-942-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/03/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35604/03/2015
    Labeler - DZA Brands LLC (090322194)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55316-942)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55316-942)
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