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 October 3, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • claims

    GOODSENSE
    Alcohol Free Antiseptic Oral Rinse

    SEALED WITH PRINTED

    NECKBAND FOR YOUR PROTECTION

  • 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 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.

  • 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 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

  • SPL UNCLASSIFIED SECTION

    This rinse may cause temporary staining 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 of

    Crest Pro-Health Multi-Protection Alcohol Free Rinse-Refreshing Clean Mint

    **Killed at least 99% of representative plaque organisms commonly

    associated with gingivitis in as little as 15 seconds

    Distributed by: Perrigo Direct, Inc.

    Peachtree City, GA 30269

    www.PerrigoDirect.com

    1-888-593-0593

    GoodSense is a registered trademark of L. Perrigo Company.

  • principal display panel

    GOODSENSE
    Alcohol Free Antiseptic Oral Rinse

    Antigingivitis/Antiplaque

    Mint Flavor

    Kills 99% of Germs for a healthier Mouth**

    Helps prevent Plaque
    Helps prevent gingivitis
    Helps keep teeth feeling clean
    Freshens Breath
    No burn of alcohol
    Compare to active ingredients of Crest Pro-Health Rinse*

    1 LITER (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-299
    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:50804-299-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/20/1993
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35609/20/1993
    Labeler - Perrigo Direct, Inc (076059836)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(50804-299)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(50804-299)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!