VITAL-KETODINE (CHLORHEXIDINE GLUCONATE AND KETOCONAZOLE) SHAMPOO [VITAL ANIMAL HEALTH]

VITAL-KETODINE (CHLORHEXIDINE GLUCONATE AND KETOCONAZOLE) SHAMPOO [VITAL ANIMAL HEALTH]
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NDC 60255-333-16, 60255-333-28
Set ID fef89764-5cfb-401a-a519-f38a0dfe790a
Category OTC ANIMAL DRUG LABEL
Packager Vital Animal Health
Generic Name
Product Class
Product Number
Application Number
  • 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

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