Label: PERCARA ORAL HEALTH RINSE FRESH MINT- cetylpyridinium chloride rinse

  • NDC Code(s): 67933-0321-1
  • Packager: LEC Custom Products, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient
    Cetylpyridinium chloride 0.07%

  • PURPOSE

    Purpose

    Antigingivitis

    Antiplaque

  • INDICATIONS & USAGE

    Use helps control plaque that leads to gingivitis.

  • WARNINGS

    Warning

    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 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.

  • DOSAGE & ADMINISTRATION

    Directions

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

    Other Information

    this rinse is not intended to replace brushing or flossing

  • INACTIVE INGREDIENT

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

  • SPL UNCLASSIFIED SECTION

    Distributed by: LEC Custom Products, Inc. Mississauga, ON. L5S 1B8

    Made in Canada

  • PRINCIPAL DISPLAY PANEL

    PERCARA™

    FRESH MINT

    ORAL HEALTH RINSE

    ALCOHOL FREE

    KILLS GERMS

    FRESHENS BREATH

    PREVENTS GINGIVITIS

    16.9 FL OZ (500mL)

    PerCara Oral Health Rinse

  • INGREDIENTS AND APPEARANCE
    PERCARA ORAL HEALTH RINSE  FRESH MINT
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67933-0321
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.07 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67933-0321-1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02103/15/2021
    Labeler - LEC Custom Products, Inc (204065726)
    Establishment
    NameAddressID/FEIBusiness Operations
    LEC Custom Products, Inc204064757manufacture(67933-0321)
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