Label: EQUATE HEALTHY GUMS CLEAN MINT BREATH ORAL RINSE- cetylpyridinium chloride liquid

  • NDC Code(s): 84239-000-00
  • Packager: Vasu Healthcare Pvt. Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2024

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

  • Drug Facts

  • Active Ingredient

    Cetylpyridinium Chloride 0.05%

    Purpose

    Anti-Gingivitis/Anti-Plaque

  • Uses

    • Helps reduce Plaque-associated Gingivitis
    • Helps control gum infections
  • Warnings

    Stop use and ask Dentist if

    • 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 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.

  • Directions

    Adults and children 12 years and older : Measure 20ml (4 teaspoonful) and vigorously swish around the mouth and between teeth for 1 minute then spit out. Use undiluted, twice daily, in morning & before bedtime.

    Children 6 years to under 12 years : Under Adult supervision

    Children under 6 years : Not recommended for use

    • Do not swallow. In case as excess quantity is swallowed accidently, contact Poison Control Center for immediate care and attention.
  • Other information

    Do not exceed the recommended dosage. This rinse is not a substitute for brushing or flossing. Do not use if safety seal is broken or missing.

  • Inactive ingredients

    Water, Glycerin, PEG-40 Hydrogenated castor oil, Sodium benzoate, Citric acid, Flavour, Sucralose

  • Package Labelling:

    Label.jpg

  • INGREDIENTS AND APPEARANCE
    EQUATE HEALTHY GUMS CLEAN MINT BREATH ORAL RINSE 
    cetylpyridinium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84239-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84239-000-00475 mL in 1 BOTTLE; Type 0: Not a Combination Product01/25/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/25/2025
    Labeler - Vasu Healthcare Pvt. Ltd. (930225721)