Label: KETOMAX TRIS FLUSH- ketoconazole solution

  • NDC Code(s): 68898-120-08, 68898-120-12
  • Packager: Animal Pharmaceuticals
  • 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 21, 2022

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

  • Drug Facts

  • Active Ingredients

    Ketoconazole, USP 0.1%

  • Purpose

    Antifungal

  • Inactive Ingredients

    Water, SD Alcohol-40B, Nonoxynol-9, Disodium EDTA, Benzyl Alcohol, Fragrance, Tromethamine Technical Grade.

  • Uses:

    a medicated cleansing solution with antimicrobial and antifungal activity for dogs and cats.

  • Directions for Use:

    Shake well before use. Apply liberally to the affected area(s). Apply twice daily or as directed by veterinarian. Use cotton or absorbent material to clean excess solution and wipe away debris. Do not allow the animal to lick the treated area until dry to prevent ingestion. Wash hands after use.

  • Precautions

    For topical use in animals only. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of contact with eyes or mucous membranes, flush with copious amounts of water for 5-10 minutes. If irritation persists seek medical attention immediately.

  • SPL UNCLASSIFIED SECTION

    A Ready-To-Use Antimicrobial and Antifungal Cleansing Solution.

    Formulated for Dogs and Cats

    At Animal Pharmaceuticals we strive to provide the best nutritional and topical treatments for your pet by going above and beyond....and we don't stop there. We know that caring for your pet is just as important as caring for your own health, so we've developed and implemented systems that make things easier on you and convenient for your Veterinarian.

    OUR ASSURANCE
    Animal Pharmaceuticals products are designed with our proprietary technology that helps retrieve and sustain the nutrients and healthful ingredients. Our proprietary formulation enhances the effects of functional ingredients and penetrates the skin and the effective areas to exert the corrective results.

    Additionally, and as always, you'll find that all our bottles and containers are made of recyclable plastic. Please help us protect the environment by recycling.

    ALL PRODUCTS ARE MADE IN THE U.S.A. AND 100% QUALITY GUARANTEED.

    To learn more about our products, visit:

    www.anmpharm.com

    SOLD EXCLUSIVELY THROUGH LICENSED VETERINARIANS

    MANUFACTURED FOR
    Animal Pharmaceuticals

    MADE IN THE USA

  • Packaging

    Anm-120

  • INGREDIENTS AND APPEARANCE
    KETOMAX TRIS FLUSH 
    ketoconazole solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:68898-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68898-120-08237 mL in 1 BOTTLE, PLASTIC
    2NDC:68898-120-12355 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/15/2021
    Labeler - Animal Pharmaceuticals (166472444)
    Registrant - Stratford Care Usa, Inc. (036650469)