Label: CLEANZING- cetylpyridium chloride solution

  • 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 December 29, 2015

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  • Active Ingredient:

    Cetylpyridium Chloride 0.06%

  • Purpose:

    Anti gingivitis/Anti plaque

  • Use:

    Aids in reducing plaque and gingivitis

  • Warnings:

    Ask your dentist if symptoms persist or condition worsens after regular use. 

  • Keep out of reach of children:

    If more than 1 oz. is accidentally swallowed, get medical attention or contact a poison control center right away.

  • Directions:

    - Adults or children 6 years or older:
    - Rinse mouth and swish for 30 seconds twice a day 

  • Inactive Ingredients:

    Glycerin, Green Tea Extract, Natural Flavors, Sodium Benzoate, Xylitol

  • PRINCIPAL DISPLAY PANEL

    label of package

  • INGREDIENTS AND APPEARANCE
    CLEANZING 
    cetylpyridium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-375
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.283 g  in 473 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-375-06473 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/31/2015
    Labeler - Geritrex LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geritrex LLC112796248manufacture(54162-375)
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