KETO-C-TRIS FLUSH (KETOCONAZOLE) SOLUTION [STRATFORD PHARMACEUTICALS]

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KETO-C-TRIS FLUSH (KETOCONAZOLE) SOLUTION [STRATFORD PHARMACEUTICALS]
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NDC 86069-111-12
Set ID fa1bf5ed-9923-4b56-b617-c9a75e7d3d97
Category OTC ANIMAL DRUG LABEL
Packager Stratford Care Usa, Inc.
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENT

    Active Ingredients: Ketoconazole 0.1%​

  • PURPOSE

    ​Topical Antiseptic Solution 

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN

  • 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.​

  • 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

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

  • STORAGE AND HANDLING

    ​Storage:​ Store at controlled room temperature; protect from freezing.

  • INACTIVE INGREDIENT

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

  • SPL UNCLASSIFIED SECTION

    ​For Dogs & Cats​

    Topical Antiseptic Solution for Cleansing and Flushing of Ears and Skin.

    FOR VETERINARY USE ONLY

    Available Through Licensed Veterinarians Only.

    Manufactured for:
    Stratford Pharmaceuticals
    Oldsmar, FL 34677
    877-498-2002
    www.stratfordrx.com

  • Packaging

    Ketoc111

    IMAGE

    IMAGE

  • 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)
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