Label: FIXODENT GUM CARE- cetylpyridinium chloride rinse

  • NDC Code(s): 37000-169-01, 37000-169-15, 37000-169-25, 37000-169-36, view more
    37000-169-50
  • Packager: The Procter & Gamble Manufacturing 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 January 20, 2022

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Cetylpyridinium chloride 0.07%

  • Purpose

    Antigingivitis/antiplaque

  • Uses

    • helps prevent and reduce plaque and gingivitis
    • helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums
  • Warnings

    Ask a dentist if symptoms persist or condition worsens after regular use.

    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

    • use after your normal brushing and flossing routine; rinse toothpaste from mouth prior to use
    • adults and children 6 yrs. & 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
  • Inactive ingredients

    water, glycerin, flavor, poloxamer 407, sodium saccharin, methylparaben, sucralose, propylparaben, blue 1

  • Questions?

    1–800–214-8871

  • SPL UNCLASSIFIED SECTION

    DISTR. BT PROCTER & GAMBLE,

    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 250 ML Bottle Label

    ALCOHOL FREE

    FRESHENS BREATH

    from the makers of

    #1

    Denture Adhesive Brand

    Fixodent®
    CPC ANTIGINGIVITIS/ANTIPLAQUE ORAL RINSE

    GUM CARE

    CLEANS & PROTECTS GUMS

    For Partials and Denture Wearers woth Some Natural Teeth

    250 mL (8.4FL OZ)

    169

  • INGREDIENTS AND APPEARANCE
    FIXODENT  GUM CARE
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-169
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.07 g  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorWINTERGREENImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-169-3636 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/2018
    2NDC:37000-169-25250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/2018
    3NDC:37000-169-50500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/2018
    4NDC:37000-169-011000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/2018
    5NDC:37000-169-151500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35611/28/2018
    Labeler - The Procter & Gamble Manufacturing Company (004238200)