Label: MULTI-ACTION ANTISEPTIC- cetylpyridinium chloride rinse

  • NDC Code(s): 41520-299-86
  • Packager: American Sales Company
  • 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 February 14, 2023

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  • OTHER SAFETY INFORMATION

    Sealed With Printed Neckband For Your Protection

    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, bleeding or redness persists for more than 2 weeks
    • you have painful or swollen gums, pus from the gun 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 brushng, 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

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

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

    DISTRIBUTED BY:

    Foodhold U.S.A., LLC

    Landover, MD 20785

    1-877-846-9949

    (c) 2018 S&S Brands, LLC

    Quality guaranteed or your money back

  • principal display panel

    CAREONE

    *Compare to Crest Pro health Clean Mint*

    MULTI-ACTION

    ANTISEPTIC ORAL RINSE

    ANTIGINGIVITIS/ANTIPLAQUE

    KILLS GERMS

    ALCOHOL-FREE

    VIVID MINT FLAVOR

    HELPS PREVENT PLAQUE

    HELPS PREVENT GINGIVITIIS 

    FRESHENS BREATH

    33.8 FL OZ (1.05 QT) 1 L

    image description

  • INGREDIENTS AND APPEARANCE
    MULTI-ACTION ANTISEPTIC 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-299
    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:41520-299-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/25/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35604/25/2018
    Labeler - American Sales Company (809183973)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(41520-299)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(41520-299)
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