KetoWELL: Product Information

KETOWELL- chlorhexidine gluconate and ketoconazole shampoo
Holden2 LLC

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% and Ketoconazole 1%.

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.

Formulated for Dogs, Cats, & Horses

Cucumber-Melon Scent

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

MFG IN USA

Packaging

KETOWELL chlorhexidine gluconate, ketoconazole shampoo

Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86090-004 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 LAURAMINE OXIDE COCAMIDOPROPYL BETAINE POLYACRYLATE-1 CROSSPOLYMER DECYL GLUCOSIDE GLYCOLIC ACID EDETATE SODIUM METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE

Product Characteristics Color pink Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:86090-004-08 237 mL in 1 BOTTLE, PLASTIC None 2 NDC:86090-004-16 473 mL in 1 BOTTLE, PLASTIC None

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

Labeler — Holden2 LLC (060164988)

Revised: 03/2023 Holden2 LLC