Label: ORAL-B ANTI-BACTERIAL- cetylpyridinium chloride liquid

  • 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 April 2, 2010

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Cetylpyridinium Chloride 0.05%

  • Purpose

    Anti-bacterial

  • Use

    To fight plaque and bad breath bacteria.

  • Warnings

    Keep out of the reach of children.

    Not for use by children under six years of age.

    Children over six should be supervised when using this product.

    Do not use if shrinkband is broken or missing.

    Do not swallow.

  • Directions

    Rinse twice daily, after brushing, with 1/2 a capful (15 ml) for about 30 seconds.

  • Other information

    Store above freezing.

  • Inactive ingredients

    Water, Glycerin, Alcohol (9.3%), Flavor, Poloxamer 407, Methylparaben, Sodium Saccharin, Propylparaben, FD&C Blue #1, and D&C Yellow #10

  • Question or comments?

    1-800-56-ORALB
    http://www.oralb.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Oral-B, A Division of
    Procter & Gamble
    Cincinnati, OH 45202

    © Oral-B Laboratories

    Made in Colombia

  • PRINCIPAL DISPLAY PANEL - 500ml Label

    Oral -B®

    Anti-Bacterial Rinse

    • Dual action formula kills
      plaque and bad breath
      bacteria on contact

    NATURAL
    MINT
    FLAVOR

    16.9 oz / 500ml

    Principal Display Panel - 500ml Label
  • INGREDIENTS AND APPEARANCE
    ORAL-B  ANTI-BACTERIAL
    cetylpyridinium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0041-1420
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Cetylpyridinium Chloride (UNII: D9OM4SK49P) (Cetylpyridinium - UNII:CUB7JI0JV3) Cetylpyridinium Chloride500 ug  in 1 mL
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0041-1420-16500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35610/15/2005
    Labeler - Oral-B Laboratories (183102243)
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!