Keto-C-Tris WIPES: Product Information

KETO-C-TRIS WIPES- ketoconazole cloth
Stratford Care Usa, Inc.

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.

Active Ingredients: Ketoconazole 0.1%.

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

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

Directions for Use: Apply liberally to the affected area(s). Apply twice daily or as directed by veterinarian. 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

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

For Dogs & Cats

Available Through Licensed Veterinarians Only.

Manufactured for:
Stratford Pharmaceuticals
Odessa, FL 33556
877-498-2002
www.stratfordrx.com

MADE IN THE USA

Packaging

wipes116
(click image for full-size original)

KETO-C-TRIS WIPES
ketoconazole cloth
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86069-116
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOCONAZOLE (KETOCONAZOLE) KETOCONAZOLE 0.1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
NONOXYNOL-9
EDETATE DISODIUM ANHYDROUS
BENZYL ALCOHOL
TROMETHAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86069-116-10 100 PACKAGE in 1 CONTAINER contains a PACKAGE
1 0.1 g in 1 PACKAGE This package is contained within the CONTAINER (86069-116-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/24/2021
Labeler — Stratford Care Usa, Inc. (036650469)

Revised: 04/2021 Stratford Care Usa, Inc.

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