Label: HEXACHLOR-K- chlorhexidine gluconate and ketoconazole shampoo, suspension

  • 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 December 8, 2021

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

  • VETERINARY INDICATIONS

    HexaChlor-K Shampoo promotes healthy skin for animals with conditions responsive to ketoconazole and/or chlorhexidine.

  • DESCRIPTION

    ACTIVE INGREDIENTS: 2% Chlorhexidine Gluconate, USP; 1% Ketoconazole, USP

  • SPL UNCLASSIFIED SECTION

    ALSO CONTAINS: Water, Lauramine Oxide, Cocamidopropyl Betaine, Polyacrylate-1 Crosspolymer, Acetic Acid, Decyl Glucoside, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Shake well before using. Apply to wet coat, rub onto skin and haircoat to create a rich lather. Allow shampoo to remain on skin and coat for 5-10 minutes. Rinse well. Use initially 2 to 4 times per week for 4 weeks, then reduce to once per week or as directed by veterinarian. For best results follow with GlenHaven HexaChlor-K Spray.

  • WARNINGS

    CAUTION: For topical use only. Avoid contact with eyes. If skin irritation develops or increases, stop use and call your veterinarian. Keep out of the reach of children and pets.

    HUMAN WARNING: Wash hands after use. Rare but serious allergic reactions have been reported with exposure to chlorhexidine gluconate.

  • HOW SUPPLIED

    STORAGE: Store at room temperature.

  • SPL UNCLASSIFIED SECTION

    Available through licensed veterinarians.

    Manufactured for:
    GlenHaven
    18101 SE 6th Way
    Vancouver, WA 98683

    39647 REV02/21

  • PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label

    NDC 70782-132-12

    GlenHaven™
    Therapeutics

    Medically Formulated

    HexaChlor-K
    Shampoo

    Formerly F3/S

    Antimicrobial,
    antifungal

    Acetic acid, chlorhexidine,
    ketoconazole

    For Dog and Cat Use Only

    Net Contents: 12 FL OZ. (355 mL)

    PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    HEXACHLOR-K 
    chlorhexidine gluconate and ketoconazole shampoo, suspension
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:70782-132
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70782-132-12355 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER06/01/2016
    Labeler - GlenHaven LLC (002542300)
    Registrant - Dechra Veterinary Products (362142734)