Label: HEXZOLE- chlorhexidine gluconate and ketoconazole shampoo

  • NDC Code(s): 51437-101-04, 51437-101-16
  • Packager: Nootie LLC
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 10, 2021

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  • PURPOSE

    Uses: A medicated shampoo with a broad spectrum of antibacterial and antifungal activity for dogs, cats and horses.

  • PRINCIPAL DISPLAY PANEL

    hexzole16

  • INGREDIENTS AND APPEARANCE
    HEXZOLE 
    chlorhexidine gluconate and ketoconazole shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:51437-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20.6 mg  in 1 mL
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE10 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51437-101-04118 mL in 1 BOTTLE, PLASTIC
    2NDC:51437-101-16473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/2013
    Labeler - Nootie LLC (008995795)
    Registrant - Custom Veterinary Services, Inc. (619511483)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Veterinary Services, Inc.619511483manufacture, api manufacture