Label: DUOCARE CLINICAL ORAL RINSE- cetylpyridinium chloride mouthwash

  • NDC Code(s): 53329-030-07, 53329-030-13
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 16, 2023

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

View All Sections
  • Active ingredient

    Cetylpyridinium Chloride 0.1%

  • Purpose

    Antigingivitis/Antiplaque

  • Uses

    • helps prevent and reduce plaque that leads to gingivitis and bleeding gums
  • Warnings

    Stop use and ask a doctor 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 increasingspacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

    Keep out of reach of children.

    If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 12 years of age and older: swish 7 ml of rinse between your teeth for approximately one minute and then spit out. Do not swallow the rinse.
    • Use up to 4 times daily or as directed by dentist or doctor.
    • children 6 years to under 12 years of age: supervise use.
    • children under 6 years of age: consult a dentist or a doctor.
  • Other information

    • avoid excessive heat and protect from freezing
    • shield from direct sunlight
  • Inactive ingredients

    citric acid, glycerin, methyl salicylate, poloxamer 407, purified water, sodium citrate, sucralose, supermint

  • Manufacturing Information

    Manufactured for:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in the USA with U.S. and Foreign Components.

    www.medline.com

    1-800-MEDLINE (633-5463)

    REF: MDS096316

    V1 RC22ANO

  • Package Label

    PDP

  • INGREDIENTS AND APPEARANCE
    DUOCARE CLINICAL ORAL RINSE 
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-030
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-030-1359 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
    2NDC:53329-030-077 mL in 1 POUCH; Type 0: Not a Combination Product11/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02211/01/2018
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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!