Malaseb: Product Information

MALASEB- chlorhexidine gluconate and miconazole nitrate shampoo
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.

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.

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

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.

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.

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

Store at room temperature. Protect from freezing.

Available through licensed veterinarians.

For Veterinary Use Only.

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-8 REV08/22

PRINCIPAL DISPLAY PANEL — 236 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

8 fl. oz. (236 mL)

Dechra

PRINCIPAL DISPLAY PANEL -- 236 mL Bottle Label
(click image for full-size original)
MALASEB
chlorhexidine gluconate and miconazole nitrate shampoo
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:17033-185
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 20 mg in 1 mL
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 20 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17033-185-08 236 mL in 1 BOTTLE None
2 NDC:17033-185-16 473 mL in 1 BOTTLE None
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)

Revised: 09/2022 Dechra Veterinary Products

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