Label: DAVIS KETOHEXIDINE- chlorhexidine and ketoconazole shampoo

  • NDC Code(s): 62570-040-01, 62570-040-12
  • Packager: Davis Manufacturing and Packaging Inc
  • 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 May 4, 2023

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

  • DESCRIPTION

    Davis KetoHexidineTM Shampoo combines two highly effective ingredients, Ketoconazole and Chlorhexidine Gluconate, to help attack problems associated with bacteria, yeast and fungi. Formulated to provide a therapeutic bath and promote healthy skin and coat, it washes away the microorganisms that can lead to skin conditions. The added benefit of Colloidal Oatmeal helps to soothe and moisturize. Davis KetoHexidine Shampoo refreshes with a light mint fragrance and may be used on all dogs, cats and horses.

  • SPL UNCLASSIFIED SECTION

    MADE IN THE USA

    Davis Manufacturing

    541 Proctor Avenue

    Scottdale, GA 30079 (Atlanta)

    www.davismfg.com

  • ACTIVE INGREDIENT

    Active Ingredients: 2% Chlorhexidine Gluconate, 1% Ketoconazole

  • INACTIVE INGREDIENT

    Inactive Ingredients: Purified Water, Ammonium Laureth Sulfate, Cocamidopropyl Betaine (and) Cocamide MEA, Ethylene Glycol Monostearate, Colloidal Oatmeal, Aloe Vera, Peppermint Fragrance, Methylchloroisothiazolinone (and) Methylisothiazolinone

  • DIRECTIONS FOR USE

    Shake well before using.  Wet coat thoroughly with warm water. Apply shampoo to head and ears, then lather.  Do not get shampoo into eyes. Repeat procedure with neck, chest, middle, and hindquarter, finishing with legs.  Allow shampoo to be absorbed for 5 to 10 minutes then rinse thoroughly.

  • DOSAGE & ADMINISTRATION

    May be used initially 2 to 3 times a week for four weeks, then reducing to once a week, or as directed by your veterinarian.

  • WARNINGS AND PRECAUTIONS

    Wash Hands After Use

    For animal use only.  Avoid contact with eyes or mucous membranes. Not for otic use. If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

  • KEEP OUT OF REACH OF CHILDREN

    For External Usse Only Keep Out of Reach of Children and Pets

  • PRINCIPAL DISPLAY PANEL

    Davis Veterinary Products

    KetoHexidineTMShampoo

    with 2% Chlorhexidine Gluconate and 1%Ketoconazole

    FOR DOGS, CATS, AND HORSES

    Helps manage skin problems associated with bacterial dermititis, seborrhea, yeast and fungi

    12 Fl. Oz. (355 ml)

    62570-040-12.

  • PRINCIPAL DISPLAY PANEL

    Davis Veterinary Products

    KetoHexidineTM Shampoo

    with 2% Chlorhexidine Gluconate and 1%Ketoconazole

    FOR DOGS, CATS, AND HORSES

    Helps manage skin problems associated with bacterial dermititis, seborrhea, yeast and fungi

    1 Gallon (3.785 Liters)

    62570-040-01

  • INGREDIENTS AND APPEARANCE
    DAVIS KETOHEXIDINE 
    chlorhexidine and ketoconazole shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:62570-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE2 g  in 100 g
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    OATMEAL (UNII: 8PI54V663Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62570-040-12355 g in 1 BOTTLE
    2NDC:62570-040-013785 g in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/02/2017
    Labeler - Davis Manufacturing and Packaging Inc (106680523)
    Registrant - Davis Manufacturing and Packaging Inc (106680523)
    Establishment
    NameAddressID/FEIBusiness Operations
    Davis Manufacturing and Packaging Inc106680523api manufacture