Keto-C XL Wipes 60 Count: Product Information

KETO-C XL WIPES 60 COUNT- chlorhexidine gluconate and 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: Chlorhexidine Gluconate USP 2%, Ketoconazole USP 1%.

Antiseptic

KEEP OUT OF THE REACH OF CHILDREN

Keto-C^® XL Wipes contain 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: Water, Propylene Glycol, Nonoxynol-9, Lactic Acid, Polysorbate 20, Aloe Barbadensis (Aloe) Leaf Juice, Glycerine, Fragrance, Methylisothiazolinone.

For Dogs & Cats

FOR VETERINARY USE ONLY

Available Through Licensed Veterinarians Only.

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

MADE IN THE USA

Packaging

KETO-C XL WIPES 60 COUNT chlorhexidine gluconate, ketoconazole cloth

Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86069-115 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 2 g in 100 mL KETOCONAZOLE (KETOCONAZOLE) KETOCONAZOLE 1 g in 100 mL

Inactive Ingredients Ingredient Name Strength WATER PROPYLENE GLYCOL NONOXYNOL-9 LACTIC ACID, UNSPECIFIED FORM POLYSORBATE 20 ALOE VERA LEAF GLYCERIN METHYLISOTHIAZOLINONE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:86069-115-60 60 PACKAGE in 1 CONTAINER contains a PACKAGE 1 0.15 mL in 1 PACKAGE This package is contained within the CONTAINER (86069-115-60)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/01/2021

Labeler — Stratford Care Usa, Inc. (036650469)

Revised: 03/2021 Stratford Care Usa, Inc.