Label: PARODONTAX ACTIVE GUM HEALTH DAILY MOUTHWASH BREATH FRESHENER- cetylpyridinium chloride liquid

  • NDC Code(s): 0135-0652-02, 0135-0652-03
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 8, 2024

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

View All Sections
  • Active ingredient

    Cetylpyridinium chloride 0.07% w/w

  • Purposes

    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(500 mL)

    ■ adults and children 6 years of age and older:measure twice up to 10 milliliters mark inside of cap. Vigorously swish 20 milliliters 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:supervise use

    ■ children under 6 years of age:do not use

  • Directions(1000 mL)

    ■ adults and children 6 years of age and older: vigorously swish 20 milliliters (4 teaspoonfuls) of 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: supervise use

    ■ children under 6 years of age: do not use

  • Other information

    ■ this product is not intended to replace brushing or flossing

    ■ may cause staining

    ■ do not store above 25°C (77°F)

  • Inactive ingredients

    water, glycerin, poloxamer 407, flavor, benzoic acid, sodium benzoate, sucralose, zinc lactate, sodium saccharin, green 3, yellow 6, cinnamal

  • Questions or comments?

    1-866-844-2797

  • Generic Section

    ALWAYS FOLLOW THE LABEL
    Do not use if printed safety seal around cap is broken or missing.
    Pat. Info www.productpats.com

    Distributed by: Haleon,Warren, NJ 07059

    Trademarks owned or licensed by Haleon.

    ©2023 Haleon or licensor.

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

    BOTTLE
    RECYCLE

    CAP
    CHECK LOCALLY

    †Recycling facilities for this product may not exist in your area

    206167
    L0021380BA

  • Principal Display Panel

    NEW

    HALEON

    parodontax

    CETYLPYRIDINIUM CHLORIDE
    ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

    DAILY MOUTHWASH

    HELPS PREVENT
    BLEEDING GUMS
    & BAD BREATH
    BACTERIA

    BREATH CLEANSE TECHNOLOGY

    BREATH FRESHENER

    KILLS 99.9%
    PLAQUE BACTERIA*

    ALCOHOL FREE

    NET WT 16.9 FL OZ (500 mL)

    206166
    L0021380FA

    Parodontax Active Gum Health MW 500 mL
  • INGREDIENTS AND APPEARANCE
    PARODONTAX   ACTIVE GUM HEALTH DAILY MOUTHWASH BREATH FRESHENER
    cetylpyridinium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0652
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0652-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/02/2024
    2NDC:0135-0652-031000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/02/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/02/2024
    Labeler - Haleon US Holdings LLC (079944263)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!