Label: HEALTH- cetylpyridinium chloride mouthwash

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 23, 2024

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  • Tamper Evident Statement

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION.

  • Claims

    KILLS GERMS THAT CAUSE

    • Plaque
    • Gingivitis
    • Bad Breath
  • Disclaimer

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

  • Active ingredients

    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 secnds 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, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

  • Disclaimer

    *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

    Old East Main

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

    100% Satisfaction Guaranteed (888)309-9030

  • Adverse Reaction

    DISTRIBUTED BY Old East Main Co.

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

    100% Satisfaction Guaranteed (888)309-9030

  • Principal display panel

    DG ®health

    Compare to Crest ®Pro-Health ®Multi-Protection Refreshing Clean Mint*

    ALCOHOL-FREE

    ANTISPETIC

    ORAL RINSE

    Antigingivitis / Antiplaque

    Mouth Rinse

    VIVID MINT

    MULTI-ACTION

    • Helps Prevent plaque
    • Helps Prevent gingivitis
    • Helps keep teeth feeling clean
    • Freshens breath
    • No burn of alcohol

    33.8 FL OZ (1.05 QT) 1 L

    image description

  • Principal display panel

    Since 1903

    Rexall

    Alcohol-Free

    Antiseptic

    Oral Rinse

    Antigingivitis/Antiplaque

    MULTI-ACTION

    • Kills germs commonly associated with gingivitis
    • Helps prevent plaque
    • No burn of alcohol

    VIVID MINT FLAVOR

    1 L (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    HEALTH 
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-299
    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:55910-299-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/21/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)07/21/2008
    Labeler - Old East Main. Co (068331990)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(55910-299)
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