Label: ANTISEPTIC- cetylpyridinium chloride rinse

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

Drug Label Information

Updated August 29, 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

  • 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 spaceing 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 ingredents

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

  • SPL UNCLASSIFIED SECTION

    For Better Oral

    Hygiene and Fresher Breath

    • Kills Germs
    • Helps Prevent Plaque
    • Helps Prevent Gingivitis
    • Helps Keep teeth feeling clean
    • Freshens breath
    • No Burn of Alcohol

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

    *This product is not manufactured or distributed by Procter & Gamble, distributor Crest Pro-Health Rinse.

    DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC.,

    10401 MONROE RD, MATTHEWS, NC 28105 USA

    Made in U.S.A. with U.S. and foreign components

    Not 100% satisfied? Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

  • principal display panel

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    COMPARE TO ACTIVE INGREDIENT IN CREST PRO-HEALTH RINSE

    FAMILY WELLNESS

    100% SATISFACTION GUARANTEED OR YOUR MONEY BACK

    Multi-Action Alcohol-Free Oral Health Mouth Rinse

    Antigingivitis/Antiplaque

    • Kills Germs
    • Helps Prevent Plaque
    • Helps Prevent Gingivitis
    • Helps Keep Teeth Feeling Clean
    • Freshens Breath
    • No Burn of Alcohol

    1 L (33.8 FL OZ)

    Vivid Mint

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-299
    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:55319-299-861000 mL in 1 PACKAGE; Type 0: Not a Combination Product05/02/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)05/02/2013
    Labeler - Midwood Brands, Inc (024472631)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(55319-299)
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