Storage and handling
Store at room temperature. Protect from freezing.
Malaseb
- Manufacturer
- Dechra Veterinary Products
- Effective date
- 2024-12-12
- Label type
- OTC ANIMAL DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:44:01
Label at a glance#
ProductMalaseb
Active ingredientCHLORHEXIDINE GLUCONATE, MICONAZOLE NITRATE
Label structure9 sections
Contacts and useful links#
Websitewww.dechra-us.com
www.dechra-us.com
www.dechra-us.comLabel contents#
Full prescribing information#
VETERINARY INDICATIONS SECTION
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 SECTION
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 SECTION
Directions for Use: SHAKE WELL BEFORE EACH USE. Use in a ventilated area and prevent the animal from licking and ingesting the product during application or throughout the recommended contact time, as it may lead to gastrointestinal or respiratory tract irritation.
Wet coat thoroughly with water. Apply and lather shampoo over entire body, allowing 10 minutes of contact time. Rinse completely with water. Use weekly or as directed by your veterinarian.
PRECAUTIONS SECTION
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 SECTION
Human Warning: Wash hands after use. Rare but serious allergic reactions have been reported with exposure to chlorhexidine gluconate.
STORAGE AND HANDLING SECTION
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
Malaseb® is a registered
trademark of Dermcare-Vet Pty. Ltd.
MALSHAM-16 REV11/24-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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1116107 | chlorhexidine gluconate 2 % / miconazole nitrate 2 % Medicated Shampoo | PSN | 3 |
| 1116111 | Malaseb 2 % / 2 % Medicated Shampoo | PSN | 3 |
| 1116111 | chlorhexidine gluconate 20 MG/ML / miconazole nitrate 20 MG/ML Medicated Shampoo [Malaseb] | SBD | 3 |
| 1116107 | chlorhexidine gluconate 20 MG/ML / miconazole nitrate 20 MG/ML Medicated Shampoo | SCD | 3 |
| 1116107 | chlorhexidine gluconate 2 % / miconazole nitrate 2 % Medicated Shampoo | SY | 3 |
| 1116111 | Malaseb (chlorhexidine gluconate 2 % / miconazole nitrate 2 % ) Medicated Shampoo | SY | 3 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CHLORHEXIDINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| MICONAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| bb6d6c68-649d-4e6d-a1f6-603d969c8f68 | Product name | 1 | 20160303 |
| 3a55f4fb-5aec-4c88-0ff7-4d608ad4866a | Product name | 1 | 20140508 |
| 5b9a7965-36d2-8412-dcaf-f76a65411611 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17033-185-08 | Malaseb | 236 mL in 1 BOTTLE | SHAMPOO | 236 | 3 | |
| 17033-185-16 | Malaseb | 473 mL in 1 BOTTLE | SHAMPOO | 473 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Malaseb
- CHLORHEXIDINE GLUCONATE and MICONAZOLE NITRATE
- CHLORHEXIDINE GLUCONATE
- CHLORHEXIDINE
- MICONAZOLE NITRATE
- MICONAZOLE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 17033-185 | 17033-185-08, 17033-185-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CHLORHEXIDINE GLUCONATE | MOR84MUD8E | ACTIB |
| MICONAZOLE NITRATE | VW4H1CYW1K | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.