Keto-C XL Wipes: Product Information

KETO-C XL WIPES- ketoconazole and chlorhexidine gluconate 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 USP 0.1%, Chlorhexidine Gluconate USP 2%.​

Antiseptic

KEEP OUT OF THE REACH OF CHILDREN

Keto-C​® XL Wipes ​contains an antiseptic (antibacterial and antifungal) solution for the topical management of skin conditions that are responsive to chlorhexidine and ketoconazole. Keto-C® XL Wipes can be used for the antiseptic cleansing for face folds, finger folds, as well as underarms and groin areas.

​Directions for Use: ​Thoroughly wipe affected area with a pad 1 to 3 times per day, or as directed by your veterinarian. Do not allow the animal to lick the treated areas until dry to prevent ingestion. Wipes should be used for one application only; do not reuse. Avoid use on open wounds, cuts, or raw areas (use Keto-C® ​ Flush instead).

​Precautions: ​ Avoid contact with eyes or mucous membranes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian.

Cautions: If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

​Storage: ​ Store at room temperature. Protect from freezing.

Ingredients: ​ Propylene Glycol, Purified Water, Peg-5 Cocamide, Polyethylene Glycol 600, Benzyl Alcohol, Octyl Phenol Ethylene, Fragrance

​For Dogs & Cats

FOR VETERINARY USE ONLY

Available Through Licensed Veterinarians Only.

Manufactured for:

Stratford Care USA

Odessa, FL 33556

877-498-2002

www.stratfordrx.com

MADE IN THE USA

Packaging

KetoC1
(click image for full-size original)

KETO-C XL WIPES
ketoconazole, chlorhexidine gluconate cloth
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86069-113
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOCONAZOLE (KETOCONAZOLE) KETOCONAZOLE 1 g in 100 mL
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
WATER
PEG-5 COCAMINE
POLYETHYLENE GLYCOL 600
BENZYL ALCOHOL
4-N-OCTYLPHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86069-113-70 70 PACKAGE in 1 BOTTLE contains a PACKAGE
1 1 mL in 1 PACKAGE This package is contained within the BOTTLE (86069-113-70)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/01/2020
Labeler — Stratford Care Usa, Inc. (036650469)

Revised: 09/2020 Stratford Care Usa, Inc.

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