KETOWELL- chlorhexidine gluconate, ketoconazole spray

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 topical spray is formulated with fatty acids and Vitamin E moisturize and hydrate skin. For dogs, cats, and horses. Alcohol-free formula. Good health begins with VetWELL.

Inactive Ingredients:

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

Directions for Use:

Spray directly onto affected area(s) up to 3 times daily. Do not allow the animal to lick the area(s) 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. 

Cautions:

If undue skin irritation develops or increases, discontinue use and consult a veterinarian. KEEP OUT OF THE REACH OF CHILDREN. Consult your vet before combining with other Chlorhexidine products.

Storage:

Store at controlled room temperature. 

SPL UNCLASSIFIED SECTION

Formulated for Dogs, Cats, & Horses

ALCOHOL FREE

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

MFG IN USA

Packaging

INGREDIENTS AND APPEARANCE

KETOWELL 
chlorhexidine gluconate, ketoconazole spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86090-008
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)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
PEG-75 LANOLIN (UNII: 09179OX7TB)
SODIUM LACTATE (UNII: TU7HW0W0QT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Product Characteristics
Color	orange (Pink)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86090-008-08	237 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/31/2018

Labeler - Pet MD Brands, LLC (060164988)