Label: PARODONTAX ACTIVE GUM HEALTH MINT- cetylpyridinium chloride mouthwash
PARODONTAX ACTIVE GUM HEALTH CLEAR MINT- cetylpyridinium chloride mouthwash

  • NDC Code(s): 0135-0650-01, 0135-0651-02, 0135-0651-03
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) 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 September 16, 2022

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

  • Active ingredient

    Cetylpyridinium chloride 0.07% w/w

  • Purpose

    Antigingivitis, Antiplaque

  • Uses

    helps prevent and reduce plaque that leads to
    gingivitis, an early form of gum disease
    bleeding gums
  • Warnings

    Stop use and ask a dentist if

    irritation occurs
    gingivitis, bleeding, or redness persists for more than 2 weeks
    you have painful or swollen gums, pus from the gum line, loose teeth, or increasing 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 of age and older: vigorously swish 20 milliliters (4 teaspoonfuls) of the rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse. Do not rinse with water. Do not drink from the bottle.
    children 6 years to under 12 years of age: supervisor use
    children under 6 years of age: do not use
  • Other information

    this rinse is not intended to replace brushing or flossing
    may cause staining
    Do not store above 25°C or 77°F
  • Inactive ingredients (Mint)

    Water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

  • Inactive Ingredients (Clear Mint)

    Water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid

  • Questions or comments?

    1-855-328-5202

  • Additional Information

    *Kills plaque bacteria associated with gingivitis and odor-causing bacteria in a laboratory test

    Do not use if the printed seal on the cap is broken or missing.

    ALWAYS FOLLOW THE LABEL

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2022 GSK group of companies or its licensor.

    1-855-328-5202

  • Principal Display Panel

    NDC 0135-0651-02

    NEW

    parodontax

    CETYLPYRIDINIUM CHLORIDE ANTIGINGIVITIS/
    ANTIPLAQUE MOUTHRINSE

    ACTIVE GUM HEALTH
    DAILY MOUTHWASH

    TARGETS BACTERIA*
    & FORMS AN
    ANTIBACTERIAL SHIELD

    MINT

    KILLS 99.9%
    PLAQUE
    BACTERIA*

    16.9 FL OZ (500 mL)

    L0020006FA: Front Label

    L0020006BA: Back Label

    parodontax active gum health mouthwash mint
  • Principal Display Panel

    NDC 0135-0650-01

    NEW

    parodontax

    CETYLPYRIDINIUM CHLORIDE ANTIGINGIVITIS/
    ANTIPLAQUE MOUTHRINSE

    ACTIVE GUM HEALTH

    DAILY MOUTHWASH

    TARGETS BACTERIA*
    & FORMS AN
    ANTIBACTERIAL SHIELD

    CLEAR MINT

    DYE FREE
    ALCOHOL FREE

    16.9 FL OZ (500 mL)

    L0020007FA: Front Label

    L0020007BA: Back Label

    parodontax active gum health mouthwash clear mint
  • INGREDIENTS AND APPEARANCE
    PARODONTAX  ACTIVE GUM HEALTH MINT
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0651
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE70 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)  
    2,3'-IMINODI-BENZOIC ACID (UNII: H1C37ZB0P3)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0651-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/2022
    2NDC:0135-0651-031000 mL in 1 BOTTLE; Type 0: Not a Combination Product10/03/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/03/2022
    PARODONTAX  ACTIVE GUM HEALTH CLEAR MINT
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0650
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0650-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/03/2022
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)