MALASEB- chlorhexidine gluconate and miconazole nitrate shampoo

Malaseb by

Drug Labeling and Warnings

Malaseb 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 conditions responsive to miconazole and/or chlorhexidine and coat conditioners.

The fragrance-free shampoo base descales and degreases the hair coat without stripping.

DESCRIPTION

Active Ingredients: 2% Chlorhexidine Gluconate, USP; 2% Miconazole Nitrate, USP

Also Contains: Water, Decyl Polyglucoside, Cetrimonium Chloride, Laureth-12, PEG-120 Methyl Glucose Dioleate, Sodium Hydroxide, Acetic Acid

DOSAGE & ADMINISTRATION

Directions for Use: SHAKE WELL BEFORE EACH USE. Wet coat thoroughly with water. Apply and lather shampoo over entire body, allowing 10 minutes of contact time. Rinse completely with water. Do not allow animal to lick while bathing to prevent ingestion. Use weekly or as directed by your veterinarian.

PRECAUTIONS

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.

SAFE HANDLING WARNING

Human Warning: Wash hands after use. Rare but serious allergic reactions have been reported with exposure to chlorhexidine gluconate.

STORAGE AND HANDLING

Store at room temperature. Protect from freezing.

SPL UNCLASSIFIED SECTION

Available through licensed veterinarians.

For Veterinary Use Only.

SPL UNCLASSIFIED SECTION

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

www.dechra-us.com

Malaseb® is a registered
trademark of Dermcare-Vet Pty. Ltd.

MALSHAM-16 REV08/23-V

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

SHAKE WELL BEFORE USING

Malaseb®
Shampoo
2% Chlorhexidine Gluconate, USP
2% Miconazole Nitrate, USP
Formulated for dogs, cats
and horses
Antimicrobial, antifungal

16 fl. oz.
(473 mL)

Dechra

INGREDIENTS AND APPEARANCE

MALASEB 
chlorhexidine gluconate and miconazole nitrate shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 17033-185
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	20 mg  in 1 mL
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17033-185-08	236 mL in 1 BOTTLE
2	NDC: 17033-185-16	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		09/01/2022

Labeler - Dechra Veterinary Products (362142734)