MULTI-ACTION ANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) RINSE [GREENBRIER INTERNATIONAL, INC]

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MULTI-ACTION ANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) RINSE [GREENBRIER INTERNATIONAL, INC]
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NDC 33992-0299-7
Set ID 29f9aae0-0dd9-455d-9545-06aa91b73b24
Category HUMAN OTC DRUG LABEL
Packager Greenbrier International, Inc
Generic Name
Product Class
Product Number
Application Number PART356
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  • claims

    For better oral hygiene

    and fresher breath

    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 gun 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 ad 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 brushng, 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

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

  • Adverse reactions

    DISTRIBUTED BY GREENBRIER INTERNATIONAL, INC.

    500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

  • princpal display panel

    COMPARE TO ACTIVE INGREDIENT OF CREST PRO-HEALTH

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    ASSURED

    FRESH MINT

    ORAL

    HEALTH

    RINSE

    MULTI-ACTION ALCOHOL-FREE ANTISEPTIC

    ANTIGINGIVITIS/ANTIPLAQUE

    Kills Germs That Cause Bad Breath, Plaque and the Gum Disease Gingivitis

    Alcohol Free,

    Freshens Breath

    16.9 FL OZ (500 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    MULTI-ACTION ANTISEPTIC 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0299
    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:33992-0299-7500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/09/2017
    Labeler - Greenbrier International, Inc (610322518)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(33992-0299)
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