KETOCHLOR FOR DOGS, CATS AND HORSES- chlorhexidine gluconate and ketoconazole shampoo

KETOCHLOR by

Drug Labeling and Warnings

KETOCHLOR by is a Animal medication manufactured, distributed, or labeled by Virbac AH, Inc., Virbac Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Virbac, a pioneer in Veterinary Dermatology, offers a broad range of skin care products tailored to the individual needs of the pet, helping to improve quality of life.

USES: KETOCHLOR® Shampoo with S-I-S SKIN INNOVATIVE SCIENCE® Technology is an antiseptic shampoo for the management of conditions responsive to ketoconazole or chlorhexidine. Specifically designed to meet the needs of dogs and cats with skin barrier imbalances, KETOCHLOR shampoo is a unique cleanser, which combines ingredients that help:

• Improve hair coat and skin balance
• degreases and descales
• neutralizes unpleasant odors

Support health skin with S-I-S SKIN INNOVATIVE SCIENCE® Technology

• provides micro-organism and anti-adhesive effects (Glycotechnology)
• promotes natural skin microbial defenses (Defensin technology)

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENTS: Chlorhexidine gluconate 2.3% w/w, Ketoconazole 1% w/w.

SPL UNCLASSIFIED SECTION

INACTIVE INGREDIENTS: Acrylate C10-30 Alkyl Acrylate Crosspolymer, Alkylpolyglucoside, Butylene Glycol, Cocamidopropyl Betaine, d-Galactose, d-Mannose, FD&C Red #4, Fragrance, Hydroxypropyl Methyl Cellulose, l-Rhamnose, Lactic Acid, Laureth-2, Methylchloroisothiazolinone, PEG-90 Glyceryl Isostearate, Peumus boldus Leaf Extract, Polyquaternium-7, Purified Water, Sodium Olefin Sulfonate, Spiraea ulmaria Extract, Xanthan Gum. 

INSTRUCTIONS FOR USE

DIRECTIONS FOR USE: Shake well before use. Wet the hair coat with warm water and apply a thin line of shampoo from the base of the neck to the base of the tail. Massage shampoo over pet's body to ensure good contact with the skin. Allow to remain on hair coat for 5 to 10 minutes, then rinse thoroughly with clean water and repeat. May be used initially 2 to 3 times a week for 4 weeks, then reduce to once a week, or as directed by your veterinarian.

PRECAUTIONS

CAUTION: For animal use only.  For external use only. Avoid contact with eyes or mucous membranes. Not for otic use. If undue skin irritation develops or increases, discontinue use and consult a veterinarian. 

WARNINGS

WARNING: EYE IRRITANT.  Avoid contact with eyes. In case of contact, flush eyes with water and seek medical attention if irritation persists. In humans, rare but serious allergic reactions have been reported with products containing chlorhexidine. Wash hands after using. Keep out of reach of children.

STORAGE AND HANDLING

STORAGE: Store at controlled room temperature 59°- 86° F (15°- 30° C).

SPL UNCLASSIFIED SECTION

QUESTIONS?

Virbac AH, Inc., P.O. Box 162059, Fort Worth, Texas 76161

1-800-338-3659 us.virbac.com

PRINCIPAL DISPLAY PANEL

NDC: 51311-230-08

Virbac

KETOCHLOR®

(CHLORHEXIDINE
GLUCONATE,
KETOCONAZOLE)

MEDICATED SHAMPOO
FOR DOGS, CATS
AND HORSES

FOR MANAGEMENT OF

BACTERIAL AND FUNGAL

SKIN INFECTIONS

WARNING: Do not use if you are

allergic to chlorhexidine. See back panel

for additional warnings.

S>I>S®

S K I N

INNOVATIVE

S C I E N C E

ANTISEPTIC

& CLEANSING

8 FL. OZ. (237 mL)

INGREDIENTS AND APPEARANCE

KETOCHLOR  FOR DOGS, CATS AND HORSES
chlorhexidine gluconate and ketoconazole shampoo

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 51311-230
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	23 mg  in 1 mL
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	10 mg  in 1 mL

Product Characteristics
Color	red (RED-ORANGE)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51311-230-08	237 mL in 1 BOTTLE
2	NDC: 51311-230-16	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2002

Labeler - Virbac AH, Inc. (131568396)

Registrant - Virbac AH, Inc. (131568396)

Establishment
Name	Address	ID/FEI	Business Operations
Virbac Corporation		829166276	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Lab Express		800875106	api manufacture