Label: KETOCHLOR- chlorhexidine gluconate and ketoconazole shampoo

  • NDC Code(s): 51311-230-08, 51311-230-16
  • Packager: Virbac AH, 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 February 29, 2024

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  • MEDICATED SHAMPOO FOR DOGS AND CATS FOR MANAGEMENT OF BACTERIAL & FUNGAL SKIN INFECTIONS S-I-S® - SKIN - INNOVATIVE - SCIENCE ANTISEPTIC & CLEANSING Virbac, a pioneer in Veterinary Dermatology, offers a broad range of skin care products tailored to the individual needs of the pet, helping to improve quality of life.

    USES:

    KETOCHLOR® Shampoo with S-I-S SKIN INNOVATIVE SCIENCE® Technology is an antiseptic shampoo for the management of conditions responsive to ketoconazole or chlorhexidine. Specifically designed to meet the needs of dogs and cats with skin barrier imbalances, KETOCHLOR Shampoo is a unique cleanser, which combines ingredients that help:

    ● Improve hair coat and skin balance:
    degreases and descales
    neutralizes unpleasant odors

    ● Support healthy skin with S-I-S SKIN INNOVATIVE SCIENCE Technology
    provides micro-organism anti-adhesive effects (Glycotechnology)
    promotes natural skin microbial defenses (Defensin technology)

  • WARNING:

    Do not use if you are allergic to chlorhexidine. See back panel for additional warnings.

  • ACTIVE INGREDIENTS:

    Chlorhexidine gluconate 2.3% w/w, Ketoconazole 1% w/w.

  • INACTIVE INGREDIENTS:

    Acrylate C10-30 Alkyl Acrylate Crosspolymer, Alkylpolyglucoside, Butylene Glycol, Cocomidopropyl Betaine, d-Galactose, d-Mannose, FD&C Red #4, Fragrance, Hydroxypropyl Methyl Cellulose, l-Rhamnose, Lactic Acid, Laureth-2, Methylchloroisothiazolinone, Methylisothiazolinone, PEG-90 Glyceryl Isostearate, Peumus boldus Leaf Extract, Polyquaternium-7, Purified Water, Sodium Olefin Sulfonate, Spiraea ulmaria Extract, Xanthan Gum.

  • DIRECTIONS FOR USE:

    Shake well before use. Wet the hair coat with water and apply a thin line of shampoo from the base of the neck to the base of the tail. Massage shampoo over pet’s body to ensure good contact with the skin. Allow to remain on hair coat for 5 to 10 minutes, then rinse thoroughly with clean water and repeat. May be used initially 2 to 3 times a week for 4 weeks, then reduce to once a week, or as directed by your veterinarian.

  • CAUTION:

    For animal use only. For external 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.

  • WARNING: EYE IRRITANT.

    Avoid contact with eyes. In case of contact, flush eyes with water and seek medical attention if irritation persists. In humans, rare but serious allergic reactions have been reported with products containing chlorhexidine. Wash hands after using. Keep out of reach of children.

  • STORAGE:

    Store at controlled room temperature 59°- 86° F (15°- 30° C).

  • QUESTIONS?

    Virbac AH, Inc., P.O. Box 162059, Fort Worth, TX 76161

    1-800-338-3659

    us.virbac.com

    302230-02

    302231-02

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    KETOCHLOR 
    chlorhexidine gluconate and ketoconazole shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:51311-230
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE23 mg  in 1 mL
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE10 mg  in 1 mL
    Product Characteristics
    Colorred (RED-ORANGE) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51311-230-08237 mL in 1 BOTTLE
    2NDC:51311-230-16473 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2002
    Labeler - Virbac AH, Inc. (131568396)
    Registrant - Virbac AH, Inc. (131568396)
    Establishment
    NameAddressID/FEIBusiness Operations
    Virbac Corporation829166276manufacture, label, pack