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: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 9, 2024

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  • 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 DrugM02201/03/2022
    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 DrugM02201/03/2022
    Labeler - Haleon US Holdings LLC (079944263)
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