Label: KETO-C-TRIS FLUSH- ketoconazole solution

  • NDC Code(s): 86069-111-04, 86069-111-08, 86069-111-12
  • Packager: Stratford Care Usa, Inc.
  • Category: OTC ANIMAL DRUG LABEL

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 10, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Ketoconazole 0.1%

  • PURPOSE

    anti-fungal

  • INDICATIONS & USAGE

    Keto-C​® Tris Flush is an antiseptic (anti-fungal) solution for gentle cleansing and flushing of ears and skin. Contains Ketoconazole for the management of fungal activity. Can be used on dogs & cats.​

  • INACTIVE INGREDIENT

    ​Inactive Ingredients:​ Water, SD Alcohol 40-B, Nonoxynol-9, Disodium EDTA, Benzyl Alcohol, Fragrance, Tromethamine.

  • DOSAGE & ADMINISTRATION

    ​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

    Cautions: For animal use only. For topical use only. Avoid contact with eyes or mucous membranes. If undue skin irritation develops or increases, discontinue use and consult your veterinarian. In case of contact, flush eyes with water and seek medical attention if undue irritation persists. Keep out of the reach of children.

  • STORAGE AND HANDLING

    ​Storage:​ Store at controlled room temperature.

  • SPL UNCLASSIFIED SECTION

    MEDICATED SOLUTION

    SOLUTION FOR CLEANSING & FLUSHING OF EARS AND SKIN

    FOR DOGS & CATS

    ANTIMICROBIAL

    CUCUMBER MELON SCENT​

    Distributed by:
    StratfordCare USA
    Odessa, FL 33556
    877-498-2002
    www.stratfordrx.com

  • Packaging

    Ketoc111

  • INGREDIENTS AND APPEARANCE
    KETO-C-TRIS FLUSH 
    ketoconazole solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86069-111
    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:86069-111-12355 mL in 1 CONTAINER
    2NDC:86069-111-04118 mL in 1 BOTTLE, PLASTIC
    3NDC:86069-111-08237 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2015
    Labeler - Stratford Care Usa, Inc. (036650469)