Keto-C: Product Information

KETO-C- chlorhexidine gluconate and ketoconazole spray
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 2%, Ketoconazole 1%.

Antibacterial and antifungal

KEEP OUT OF THE REACH OF CHILDREN

Keto-C™ Spray is an alcohol-free antiseptic (antibacterial and antifungal) formulation designed for dogs, cats and horses with dermatological
conditions that are responsive to chlorhexidine and ketoconazole. It also contains Essential Fatty Acids and Vitamin E to nourish the skin and further control irritation.

Directions for Use: Spray directly onto the affected area(s) up to 3 times daily, or as directed by veterinarian. Do not allow animal to lick the treated areas until dry to prevent ingestion.

Precautions: For topical use on animals only. Avoid contact with eyes, or mucous membranes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian. Do not allow the animal to directly inhale the spray. If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

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

Storage: Store at controlled room temperature.

Inactive Ingredients: Water, Glycerine, Propylene Glycol, Polysorbate 20, Lactic Acid, PEG-75 Lanolin, Sodium Lactate, Aloe Barbadensis (Aloe) Leaf Juice, Fragrance, Methylisothiazolinone.

Formulated for Dogs, Cats & Horses

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

Keto10308
(click image for full-size original)

Keto10304
(click image for full-size original)
KETO-C
chlorhexidine gluconate, ketoconazole spray
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86069-103
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
GLYCERIN
PROPYLENE GLYCOL
POLYSORBATE 20
LACTIC ACID, UNSPECIFIED FORM
PEG-75 LANOLIN
SODIUM LACTATE
ALOE VERA LEAF
METHYLISOTHIAZOLINONE
Product Characteristics
Color orange (Pink) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86069-103-08 237 mL in 1 BOTTLE, PLASTIC None
2 NDC:86069-103-04 118 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/11/2011
Labeler — Stratford Care Usa, Inc. (036650469)

Revised: 03/2021 Stratford Care Usa, Inc.

VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VetLabel.com provides the full animal health subset of the FDA's repository. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional.

Terms of Use | Copyright © 2021. All Rights Reserved.