MALASEB- chlorhexidine gluconate and miconazole nitrate shampoo 
Teva Animal Health, 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.

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Active ingredient

2% Chlorhexidine Gluconate

2% Miconazole Nitrate

Uses

Medicated Shampoo

for Dogs and Horses

Inactive Ingredients

Peg Methyl Glucose Dioleate, Alcohols C12-15 Ethoxylated, Decyl Glucoside, Cetrimonium Chloride, Sodium hydroxide, and Purified water.

Cautions

Cautions: For topical use on dogs and horses. Avoid contact with eyes and mucous membranes. If eye contact occurs or skin irritation develops, rinse thoroughly with water, discontinue use and immediately consult your veterinarian. Available through licensed veterinarians only.

Warnings

Warnings: Keep out of reach of children

Antimicrobial

Directions

Directions: Wet coat thoroughly with water. Apply and lather Malaseb® Shampoo over the entire body, allowing 10 minutes of contact time. Rinse completely with water. Do not allow animal to lick while bathing to prevent ingestion. Repeat twice weekly until symptoms subside, then weekly, or as directed by your veterinarian.

Indications

Indications: For dermatological conditions associated with infections responsive to Miconazole Nitrate and Chlorhexidine Gluconate.

Product Description

Product Description: Malaseb® Shampoo combines a unique formulation of antibacterial and antifungal agents with coat conditioners for optimal therapeutic effectiveness. The fragrance-free shampoo base descales and degreases the hair coat without stripping.

Storage

Storage: Store at room temperature. Protect from freezing

Teva Animal Health, Inc. logo and Trademark statement

Principal Display Panel

Malaseb Shampoo Label 250mL (0.25L) (8.45fl. oz.)

Principal Display Panel

Malaseb Shampoo Label 500mL (0.5L) (16.90 fl. oz.)
MALASEB 
chlorhexidine gluconate, miconazole nitrate shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:59130-627
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE20 g  in 1 L
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE20 g  in 1 L
Packaging
#Item CodePackage Description
1NDC:59130-627-020.25 L in 1 BOTTLE, PLASTIC
2NDC:59130-627-030.5 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/23/2011
Labeler - Teva Animal Health, Inc. (625254461)
Registrant - Teva Animal Health, Inc. (625254461)
Establishment
NameAddressID/FEIBusiness Operations
Dermcare-Vet Pty Ltd758982391ANALYSIS
Establishment
NameAddressID/FEIBusiness Operations
Douglas Manufacturing Limited590829388MANUFACTURE, LABEL, PACK
Establishment
NameAddressID/FEIBusiness Operations
Yung Zip Chemical656123205API MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
RN Pharmaceuticals915786947API MANUFACTURE

Revised: 04/2013
Document Id: 4f5d02be-11ee-44ac-b1fa-c4522bdde390
Set id: c2c825a8-233c-4d2a-a4dc-da90af00cb32
Version: 2
Effective Time: 20130411
 
Teva Animal Health, Inc.