MALACETIC ULTRA- hydrocortisone and ketoconazole shampoo, suspension

MalAcetic Ultra by

Drug Labeling and Warnings

MalAcetic Ultra by is a Animal medication manufactured, distributed, or labeled by Dechra Veterinary Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VETERINARY INDICATIONS

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.

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

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.

SAFE HANDLING WARNING

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.

STORAGE AND HANDLING

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

MALACETIC ULTRA 
hydrocortisone and ketoconazole shampoo, suspension

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 17033-152
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone	10 mg  in 1 mL
Ketoconazole (UNII: R9400W927I) (Ketoconazole - UNII:R9400W927I)	Ketoconazole	1.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
XANTHAN GUM (UNII: TTV12P4NEE)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17033-152-08	236 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		06/01/2016

Labeler - Dechra Veterinary Products (362142734)