Davis MicoHexidine: Product Information

DAVIS MICOHEXIDINE- miconazole nitrate and chlorhexidine gluconate shampoo
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 MicoHexidine Shampoo^TM  is a broad spectrum antibacterial and antifungal medicated cleansing shampoo with both Miconazole Nitrate and Chlorhexidine Gluconate. These highly effective ingredients help improve the condition of the unhealthy skin or coat caused by fungi, yeast or bacteria. pH balanced and fragrance-free, it addresses conditions associated with ringworm and Malassezia dermititis including irritated skin, greasiness, loss of hair, scaly skin and poor odor. Davis MicoHexidine Shampoo washes away microorganisims that can cause itching and dry, patchy skin leaving a coat that is refreshed and clean. It is safe for use on dogs, puppies, cats, kittens, and horses.

MADE IN THE USA

Davis Manufacturing

541 Proctor Avenue

Scottdale, GA 30079 (Atlanta)

www.davismfg.com

Active Ingredient: 2% Miconazole Nitrate; 2% Chlorhexidine Gluconate

Inactive Ingredients: Purified Water, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Propylene Glycol, Cocamidopropyl Betaine and Cocamide MEA, Glycol Stearate, PEG 150 Distearate, Aloe Vera, Citric Acid, Methylchloroisothiazolinone (and) Methylisothiazolinone

Directions For Use

Shake well before using. Wet coat thoroughly with warm water. Apply shampoo to head and ears, then lather. Do not get shampoo into eyes. Repeat procedure with neck, chest middle and hindquarter, finish with legs. Allow shampoo to be absorbed for 5 to 10 minutes then rinse thoroughly.

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

Principal Display Panel 355 ml

Davis Veterinary Products

MicoHexidine^TM Shampoo

with 2% Miconazole Nitrate & 2% Chlorhexidine Gluconate

FOR DOGS, CATS AND HORSES

Helps relieve symptoms associated with bacterial and fingal infections

12 Fl. Oz. (355 ml)

Davis Veterinary Products

MicoHexidineTM Shampoo

with 2% Miconazole Nitrate & 2% Chlorhexidine Gluconate

FOR DOGS, CATS AND HORSES

Helps relieve symptoms associated with bacterial and fingal infections

1 Gallon (3.785 Liters)

DAVIS MICOHEXIDINE miconazole and chlorhexidine shampoo

Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:62570-120 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 20 mg in 1 g CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 20 g in 1 g

Inactive Ingredients Ingredient Name Strength WATER SODIUM LAURETH SULFATE SODIUM LAURYL SULFATE PROPYLENE GLYCOL COCAMIDOPROPYL BETAINE SODIUM COCO MONOETHANOLAMIDE GLYCOL STEARATE GLYCERYL 1,3-DISTEARATE ALOE VERA LEAF ANHYDROUS CITRIC ACID METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62570-120-12 355 g in 1 BOTTLE None 2 NDC:62570-120-01 3785 g in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/02/2018

Labeler — DAVIS MANUFACTURING AND PACKAGING INC (106680523)

Registrant — Vanessa Solis (106680523)

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

Revised: 06/2018 DAVIS MANUFACTURING AND PACKAGING INC