Label: DUOCARE CLINICAL ORAL RINSE- cetylpyridinium chloride mouthwash mouthwash

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 20, 2023

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  • 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 increasing spacing between the teeth. These may be the signs 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

  • Label

    Entire Label

  • INGREDIENTS AND APPEARANCE
    DUOCARE CLINICAL ORAL RINSE 
    cetylpyridinium chloride mouthwash mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83062-030(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
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83062-030-1359 mL in 1 BOTTLE; Type 0: Not a Combination Product10/06/2023
    2NDC:83062-030-077 mL in 1 POUCH; Type 0: Not a Combination Product10/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02210/06/2023
    Labeler - IIMED MEDICAL MEXICANA S DE RL DE CV (812894376)
    Registrant - Team Technologies (192339703)
    Establishment
    NameAddressID/FEIBusiness Operations
    IIMED MEDICAL MEXICANA S DE RL DE CV812894376relabel(83062-030) , repack(83062-030)
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