MALACETIC ULTRA- hydrocortisone and ketoconazole shampoo, suspension 
Dechra Veterinary Products

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.

----------

MalAcetic® Ultra Shampoo

For support of healthy skin for animals with bacterial and/or fungal skin conditions. Hydrocortisone helps promote relief for itchy skin. Ceramides aid in moisturizing, repairing, and restoring dry, damaged skin.

Active Ingredients: 1% Hydrocortisone USP, 0.15% Ketoconazole USP

Also Contains: Water, Sodium C14-16 Alpha Olefin Sulfonate, Cocamidopropyl Betaine, Disodium Cocoamphodiacetate, Sodium Lactate, Acetic Acid, Boric Acid, Hydroxypropyl Methylcellulose, Tetrasodium EDTA, Glycerine, Fragrance, PEG-8 Laurate, Laureth 4, Sodium Chloride, Ceramide Complex (Ceramide 3, Ceramide 6 II, Ceramide 1, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum), Methylchloroisothiazolinone, Methylisothiazolinone

Directions for Use: SHAKE WELL BEFORE EACH USE. Apply to wet coat, rub onto skin and haircoat until lightly lathered for 5-10 minutes. Rinse well. May be used daily or as directed by veterinarian.

Caution: For topical use only. Avoid contact with eyes. If skin irritation develops or increases, stop use and call your veterinarian. Keep out of the reach of children and pets. Wash hands after use.

Store at controlled room temperature of 20-25° C (68-77° F).

Available through licensed veterinarians only.

Made in the USA.

MUSW REV08/16

Manufactured for:
Dechra Veterinary Products
7015 College Blvd.,
Overland Park, KS 66211
www.dechra-us.com
(866) 933-2472

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

MALACETIC ULTRA Shampoo

SHAKE WELL BEFORE USING

NDC 17033-152-08

MALACETIC® ULTRA
Shampoo

Formulated for dogs, cats and
horses

Antipruritic, antimicrobial,
anti-inflammatory, moisturizing

U.S. Patent
8,722,102

8 fl. oz.
(236 mL)

Dechra

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
MALACETIC ULTRA 
hydrocortisone and ketoconazole shampoo, suspension
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17033-152
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone10 mg  in 1 mL
Ketoconazole (UNII: R9400W927I) (Ketoconazole - UNII:R9400W927I) Ketoconazole1.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
BORIC ACID (UNII: R57ZHV85D4)  
ACETIC ACID (UNII: Q40Q9N063P)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
EDETATE SODIUM (UNII: MP1J8420LU)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
LAURETH-4 (UNII: 6HQ855798J)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CERAMIDE NP (UNII: 4370DF050B)  
CERAMIDE AP (UNII: F1X8L2B00J)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
XANTHAN GUM (UNII: TTV12P4NEE)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17033-152-08236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER06/01/201609/01/2021
Labeler - Dechra Veterinary Products (362142734)

Revised: 9/2021
 
Dechra Veterinary Products