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 July 16, 2012

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  • SPL UNCLASSIFIED SECTION

    Use up + up antiseptic
    mouth rinse for better oral
    hygiene and fresher breath.
  • ACTIVE INGREDIENT

    Active ingredient
    Cetylpyridinium chloride 0.07%

    Purpose
    Antigingivitis, Antiplaque
  • INDICATIONS & USAGE

    Use helps control plaque that can lead to gingivitis
  • WARNINGS

    Warnings

    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, tet medical help or contact a Poison Control center right away.
  • 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 years to under 12 years of age: supervise use
    •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, citric acid, propylene glycol, methylparaben, propylparaben, blue 1
  • QUESTIONS

    Questions? Call 1-800-910-6874
  • ADVERSE REACTIONS

    Distributed by target Corporation
    Minneapolis, MN 55403
    Made in U.S.A. from US and foreign components
    Shop Target.com
  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by
    Procter + Gamble, distributor of Crest Pro-Health Rinse.
  • PRINCIPAL DISPLAY PANEL

    SAFETY SEALED WITH PRINTED
    NECKBAND FOR YOUR PROTECTION
    antiseptic
    mouth rinse
    alcohol free
    with CPC
    Compare to active ingredient in
    Crest Pro Health Clean Mint
    helps kill germs that cause bad breath,
    plaque and gingivitis
    Soothe + Smile
    up + up
    mint
    flavor
    50.7 FL OZ (1.5L)
    image of principal display panel
  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-299
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.07 kg  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-299-861 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/21/2008
    Labeler - Target Corporation (006961700)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture
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