Label: CEPACOL ANTIBACTERIAL- cetylpyridinium chloride liquid

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated June 22, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Cetylpyridinium chloride 0.05%

  • 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

    • 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 the 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 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse
    • children 6 years to under 12 years of age: supervise use
    • children under 6 years of age: do not use.
  • Other Information

    • this rinse is not intended to replace brushing or flossing
    • store at room temperature 20-25°C (68-77°F)
    • protect from humidity
  • Inactive ingredients

    purified water, alcohol 14% v/v, glycerin, sodium phosphate dibasic, eucalyptus oil, polysorbate 80, methyl salicylate, cinnamon oil, peppermint oil, saccharin sodium, sodium phosphate monobasic anhydrous, menthol, edetate disodium, FD&C Yellow #5

  • Questions?

    1-888-963-3382 You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Dist. by: Reckitt Benckiser
    Parsippany, NJ 07054-0224

  • PRINCIPAL DISPLAY PANEL - 710 mL Bottle Label

    NDC 63824-790-80

    Cēpacol®

    ANTIBACTERIAL*
    MULTI-PROTECTION MOUTHWASH

    CPC–Antigingivitis/Antiplaque Oral Rinse

    *Kills Germs That Cause Bad Breath

    • Reduces Plaque
    • Freshens Breath

    #1 BRAND IN HOSPITALS

    TO OPEN: Squeeze both raised finger pads
    on cap and continue to squeeze while turning.

    TO CLOSE: Turn cap until it locks completely.

    24 FL. OZ. (710 mL)

    0336220
    062111

    PRINCIPAL DISPLAY PANEL - 710 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    CEPACOL   ANTIBACTERIAL
    cetylpyridinium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-790
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Cetylpyridinium chloride (UNII: D9OM4SK49P) (Cetylpyridinium - UNII:CUB7JI0JV3) Cetylpyridinium chloride0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-790-801 in 1 CARTON06/22/2011
    1710 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35606/22/2011
    Labeler - RB Health (US) LLC (081049410)
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