Label: ANTISEPTIC- cetylpyridinium chloride rinse

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 24, 2022

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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 not finalpart35605/02/2013
    Labeler - Midwood Brands, Inc (024472631)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55319-299)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55319-299)
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