Label: ANTIGINGIVITIS/ANTIPLAQUE- cetylpyridinium chloride mouthwash

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

Drug Label Information

Updated April 5, 2024

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  • Tamper Evident Statement

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

  • Disclaimer

    QUALITY GUARANTEED

    This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurance.

    *This product is not manufactured or distributed by Procter & Gamble, distributor of Crest ®Pro-Health ®CPC Antigingivitis/Antiplaque Oral Rinse Gum and Breath Purify Smooth Mint.

  • Active Ingredient

    Cetylpyridinium Chloride 0.07%

  • Purpose

    Antigingivitis, Antiplaque

  • Use

    helps control plaque that leads to gingivitis

  • Warnings

    For this product

  • 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 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
    • when used after brushing, rinse mouth with water first
    • 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, zinc lactate, benzoic acid, sodium saccharin, sucralose, sodium benzoate, poloxamer 407, cinnamal, blue 1

  • Adverse reaction

    DISTRIBUTED BY TOPCO ASSOCIATED LLC, ITASCA, IL 60143

    ©TOPCO VIJA1123    QUESTIONS? 1-888-423-0139

    topcare@topco.com    www.topcarebrand.com

    Scan here for more information or call 1-888-423-0139

  • Principal Display Panel

    COMPARE TO CREST ® PRO-HEALTH ® ORAL RINSE GUM AND BREATH PURIFY*

    TopCare ®everyday

    ALCOHOL FREE

    Gum Defense

    Antigingivitis/Antiplaque

    Oral Rinse

    SMOOTH MINT

    • Helps improve gum hygiene
    • CPC antigingivitis/antiplaque oral rinse
    • kills germs that cause bad breath
    • helps defend against early signs of gum disease

    IMPORTANT: Read directions for proper use.

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

    image description

  • INGREDIENTS AND APPEARANCE
    ANTIGINGIVITIS/ANTIPLAQUE 
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-090
    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)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-090-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM505G(a)(3)04/05/2024
    Labeler - TopCo Associates LLC (006935977)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(76162-090)
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