Label: CHLORHEXIDINE- chlorhexidine gluconate, ketoconazole shampoo

  • Category: OTC ANIMAL DRUG LABEL

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 March 21, 2023

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  • ACTIVE INGREDIENTS:

    CHLORHEXIDINE GLUCONATE 2%

    KETOCONOZOLE 1%

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Chlorhexidine Shampoo_473mL

  • INGREDIENTS AND APPEARANCE
    CHLORHEXIDINE 
    chlorhexidine gluconate, ketoconazole shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86177-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE2 g  in 100 mL
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
    METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86177-101-16473 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/17/2023
    Labeler - PetHonesty LLC (117772515)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Veterinary Services LLC619511483manufacture, api manufacture