Davis KetoHexidine: Product Information

DAVIS KETOHEXIDINE- chlorhexidine gluconate and ketoconazole cloth
Davis Manufacturing and Packaging 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.

Davis KetoHexidine Pads are pre-moistened with a solution to tackle conditions associated with fungi, yeast, and bacteria. Use on pets experiencing irritated skin, greasiness, scaly skin and poor odor due to ringworm or Malassezia dermatitis. These gentle pads are easy to use and reach hard to clean areas like between face folds, between toes, underarms and around sensitive areas. Fragrance-free, KetoHexidine Pads wipe away microorganisms that can cause hot spots and hair loss. Safe for use on dogs, puppies, kittens and horses.

MADE IN THE USA
Davis Manufacturing
541 Proctor Avenue, Scottdale, GA 30079 (Atlanta) www.davismfg.com
Product No. KHP50 Rev. 0121

ACTIVE INGREDIENTS: Chlorhexidine Gluconate 2%, Ketoconazole 1%

INACTIVE INGREDIENTS: Water, Ethanol, Triethanolamine Lauryl Sulfate, Polyethylene glycol tert-octylphenyl ether, Propylene Glycol, Methylchloroisthiazolinione and Methylisothiazolinone

DIRECTIONS FOR USE
Treat affected area(s) 2 — 3 times daily, or as directed by a veterinarian.

Use pads to wipe affected area thoroughly. Do not get into eyes. Do not allow animal to lick the treated areas until dry to prevent ingestion. Each pad should be used once and discarded.

For animal 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.

For External Use Only. Keep Out of Reach of Children and Pets.

Davis Veterinary Products

KetoHexidine Pads

With 1% Ketoconazole and 2% Chlorhexidine Gluconate

For Dogs, Cats and Horses

Net Contents: 50 Wipes

DAVIS KETOHEXIDINE ketoconazole 1% and chlorhexidine gluconate 2% cloth

Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:62570-045 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 g KETOCONAZOLE (KETOCONAZOLE) KETOCONAZOLE 1 g in 100 g

Inactive Ingredients Ingredient Name Strength WATER TRIETHANOLAMINE LAURYL SULFATE LAURYL ALCOHOL METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE ALCOHOL OCTOXYNOL-9 PROPYLENE GLYCOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62570-045-50 50 CONTAINER in 1 PACKAGE contains a CONTAINER 1 70 g in 1 CONTAINER This package is contained within the PACKAGE (62570-045-50)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/13/2021

Labeler — Davis Manufacturing and Packaging Inc (106680523)

Establishment
Name	Address	ID/FEI	Operations
Davis Manufacturing and Packaging Inc		106680523	api manufacture

Revised: 02/2021 Davis Manufacturing and Packaging Inc