Label: GNC PET WELLNESS ULTRA MEDICATED ANTIBACTERIAL AND ANTIFUNGAL- chlorhexidine gluconate, ketoconazole shampoo

  • NDC Code(s): 43655-852-16
  • Packager: General Nutrition Corporation
  • 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 April 30, 2020

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

  • Active Ingredients:

    Chlorhexidine Gluconate 2.0%
    Ketoconazole 1.0%

  • PURPOSE

    ANTIBACTERIAL & ANTIFUNGAL

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children and pets.

  • DOSAGE & ADMINISTRATION

    Directions: Using warm water, wet coat thoroughly. Apply shampoo from base of neck to the tail, paying special attention to avoid eyes. Gently massage deep into coat and skin. Allow shampoo to remain on pet for up to 5 minutes for maximum benefit. Rinse thoroughly.

    For maximum relief, follow with GNC Pets® Itch Relief Medicated Conditioner to speed the relief of symptoms.

  • PRECAUTIONS

    Cautions: For external use only. Safe for dogs 12 weeks of age and older. In case of eye contact, flush thoroughly with water. If condition persists more than 7 days, consult veterinarian.

    Do not use more frequently than once a week. Do not use on broken or inflamed skin.

    Do not use on cats.

  • INACTIVE INGREDIENT

    Inactive Ingredients(97.0%): Water, Lauramine Oxide, Cocamidopropyl Betaine, Polyacrylate-1 Crosspolymer, Decyl Glucoside, Glycolic Acid, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone.

  • QUESTIONS OR COMMENTS?

    VISIT: GNC.COM / CALL: 877-462-4700

  • SPL UNCLASSIFIED SECTION

    for adult dogs

    Helps relieve bacterial skin infections related to allergies, grooming and scratching

    Provides relief from itching due to fungal infections

    pH balanced

    No artificial colors

    THIS FORMULA CONTAINS

    • Non-ionic surfactant formula to maintain stability of active ingredients.
    • Chlorhexidine Gluconate and Ketoconazole which may be effective in managing bacterial & fungal infections.

    GNC medicated pet grooming products are designed to go above and beyond the everyday shampoo.

    Enriched with high-quality ingredients, GNC formulas are pH balanced and will leave your pet smelling incredibly fresh, while helping

    to relieve discomfort associated with irritating skin conditions.

    GNC PETS QUALITY COMMITMENT

    Since 1935, GNC has been the leader in the development and manufacture of human nutritional supplements. GNC's commitment

    carries over to Pet Products! GNC Pet Products are produced at the highest-quality standards as our human products.

    Distributed by:

    Fetch for Pets, New York, NY 10018

    MADE IN U.S.A. with globally sourced ingredients.

    GNC Pets and the GNC Pets logo are registered trademarks of General Nutrition Centers, Inc. and are used under licence by Fetch for Pets.

    All rights reserved.

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    GNC PET WELLNESS ULTRA MEDICATED ANTIBACTERIAL AND ANTIFUNGAL 
    chlorhexidine gluconate, ketoconazole shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:43655-852
    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)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43655-852-16473 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/27/2020
    Labeler - General Nutrition Corporation (014960165)