Label: VITAL-KETODINE- chlorhexidine gluconate and ketoconazole shampoo

  • NDC Code(s): 60255-333-16, 60255-333-28
  • Packager: Vital Animal Health
  • 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 11, 2021

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

  • ACTIVE INGREDIENT

    Active Ingredients (in each dosage unit) Purpose

    Chlorhexidine Gluconate 2% (w/w) ...….................................. antibacterial

    Ketoconzaole 1% (w/w) ..…...................................................... antifungal

  • PURPOSE


    Uses

    A pleasantly scented shampoo with antiseptic activity (antibacterial and antifungal) designed for dogs, cats and horses with dermatological conditions responsive to chlorhexidine and ketoconazole.


  • WARNINGS AND PRECAUTIONS

    Warnings
    • For Animal Use Only • For topical use in dogs, cats, and horses • Avoid contact with eyes or mucous membranes • If eye contact occurs, rinse thoroughly with water and consult a veterinarian • Not for otic use • Wash hands after using • Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    Directions
    Wet the hair coat with warm water and apply a sufficient amount of Vital-KetoDine Shampoo. Massage shampoo into wet hair coat, lather freely. Allow shampoo to remain on hair for 5 to 10 minutes, then rinse thoroughly with clean water. Rinse and repeat. May be used initially 2 to 3 times a week for 4 weeks, then reducing to once a week, or as directed by your veterinarian.

  • STORAGE AND HANDLING

    Other Information

    • Store at room temperature (59°F – 86°F)
    • Protect from freezing
    • Available only through licensed Veterinarians.

  • SPL UNCLASSIFIED SECTION

    Vital-KetoDine Shampoo

    Vital Animal Health
    www.vitalanimalhealth.com

    Manufactured in USA for:
    Vital Animal Health
    2031 Rand Ave.
    Colorado Springs, CO 80905
    800-344-1165

  • PRINCIPAL DISPLAY PANEL

    Vital-KetoDine
    Shampoo

    for dogs, cats and horses
    Chlorhexidine 2%, Ketoconazole 1%

    Antiseptic shampoo in a synergistic base that offers deep cleansing and deodorizing properties

    For mild to severe dermatologic conditions where a full-strength antimicrobial, antifungal, cleansing and deodorizing shampoo may be of benefit

    16 FL OZ (474 ML)  or  1 GALLON (3.78 L)

    MADE IN THE USA

    image of label

  • INGREDIENTS AND APPEARANCE
    VITAL-KETODINE 
    chlorhexidine gluconate and ketoconazole shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:60255-333
    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
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60255-333-16474 mL in 1 BOTTLE, PLASTIC
    2NDC:60255-333-283785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/31/2013
    Labeler - Vital Animal Health (003927150)
    Registrant - Custom Veterinary Services, Inc. (619511483)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Veterinary Services, Inc.619511483manufacture, api manufacture