KETOWELL- chlorhexidine gluconate, ketoconazole shampoo

KetoWELL by

Drug Labeling and Warnings

KetoWELL by is a Animal medication manufactured, distributed, or labeled by Holden2 LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Chlorhexidine Gluconate 2% and Ketoconazole 1%.

INDICATIONS & USAGE

KetoWELL Shampoo is a pleasantly scented cleansing shampoo. The shampoo may be used on dogs, cats, and horses. Good health begins with VetWELL.

Inactive Ingredients:

Water, Lauramine Oxide, Cocamidopropyl Betaine, Polyacrylate-1 Crosspolymer, Decyl Glucoside, Glycolic Acid, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone.

Directions for Use:

Shake well before use. Wet the hair coat with warm water and apply a sufficient amount of shampoo to create a rich lather. Massage shampoo into wet hair coat, lather freely. Rinse and repeat. Allow shampoo to remain on hair for 5 to 10 minutes, then rinse thoroughly with clean water. Do not allow animal to lick or ingest product before rinsing. May be used initially 2 to 3 times a week for 4 weeks, then reduced to once a week, or as directed by your veterinarian.

Precautions:

Avoid contact with eyes or mucous membranes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian. Not for otic use. Wash hands after using. Consult your vet before combining with other Chlorhexidine products.

Cautions:

If undue skin irritation develops or increases, discontinue use and consult a veterinarian. KEEP OUT OF THE REACH OF CHILDREN.

Storage:

Store at controlled room temperature.

SPL UNCLASSIFIED SECTION

Formulated for Dogs, Cats, & Horses

Cucumber-Melon Scent

Manufactured for:
VetWELL®
Odessa, FL 33556
www.vetwell.com

MFG IN USA

Packaging

INGREDIENTS AND APPEARANCE

KETOWELL 
chlorhexidine gluconate, ketoconazole shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86090-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	2 g  in 100 mL
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYACRYLATE-1 CROSSPOLYMER (UNII: R5P9Z5WD6D)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCOLIC ACID (UNII: 0WT12SX38S)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86090-004-08	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 86090-004-16	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/21/2018

Labeler - Pet MD Brands, LLC (060164988)