Label: ANTISEPTIC- cetylpyridinium chloride rinse

  • NDC Code(s): 36800-299-21, 36800-299-86
  • Packager: Topco Associates LLC
  • 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 March 11, 2021

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 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
    • 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

  • Questions?

    Call 1-888-423-0139

  • 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 Procter & Gamble distributor of Crest Pro-Health Multi-Protection Alcohol Free Rinse-Refreshing Clean Mint

    DISTRIBUTED BY TOPCO ASSOCIATES, LLC

    ELK GROOVE VILLAGE, IL 60077

    QUESTIONS? 1-888-423-0139

    topcare@topcare.com  www.topcarebrand.com

    This Top Care product is laboratory tested to guarantee its hightest quality.  Your total satisfaction is guaranteed.

  • principal display panel

    COMPARE TO CREST PRO-HEALTH MOUTH RINSE

    TopCare

    everyday

    ALCOHOL FREE

    Oral Health

    Mouthwash

     ANTIGINGIVITIS/ANTIPLAQUE

    MINT

    • Kills germs for better oral hygiene
    • Helps reduce plaque bacteria
    • Helps prevent gingivitis
    • Freshens breath

    33.8 FL OZ (1 QT 1.8 FL OZ) 1 L

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-299
    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:36800-299-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/1993
    2NDC:36800-299-2189 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/1993
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/03/1993
    Labeler - Topco Associates LLC (006935977)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(36800-299)