Label: ANTISEPTIC- cetylpyridinium chloride rinse

  • NDC Code(s): 36800-299-21, 36800-299-86
  • Packager: Topco Associates LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 31, 2024

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  • Active ingredient

    Cetylpyridinium chloride 0.07%

    Purpose

    Antigingivitis, Antiplaque

  • USE

    helps control plaque that leads to gingivitis

  • Warnings

    for this product only

    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 gun line, loose teeth or increased 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

    • adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
    • do not swallow
    • 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
  • Inactive ingredients

    water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

  • Questions?

    Call 1-888-423-0139

  • SPL UNCLASSIFIED SECTION

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    TopCare everyday

    • Kills germs for better oral hygiene
    • Helps reduce plaque bacteria
    • Helps prevent gingivitis
    • Freshens breath

    This rinse may cause temporary staining to the surface of teeth.

    This is not harmful, and adequate brushing may prevent its occurence

    *This product is not manufactured or distributed by Procter & Gamble distributor of Crest Pro-Health Multi-Protection Alcohol Free Rinse-Refreshing Clean Mint

    DISTRIBUTED BY TOPCO ASSOCIATES, LLC

    ELK GROOVE VILLAGE, IL 60077

    QUESTIONS? 1-888-423-0139

    topcare@topcare.com  www.topcarebrand.com

    This Top Care product is laboratory tested to guarantee its hightest quality.  Your total satisfaction is guaranteed.

  • principal display panel

    COMPARE TO CREST PRO-HEALTH MOUTH RINSE

    TopCare everyday

    ALCOHOL FREE ORAL HEALTH Mouthwash

    ANTIGINGIVITIS / ANTIPLAQUE

    MINT

    • Kills germs for better oral hygiene
    • Helps reduce plaque bacteria
    • Helps prevent gingivitis
    • Freshens breath

    33.8 FL OZ (1 qt 1.8 FL OZ) 1L

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-299
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-299-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/1993
    2NDC:36800-299-2189 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/1993
    3NDC:36800-299-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/1993
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/03/1993
    Labeler - Topco Associates LLC (006935977)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(36800-299)
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