Malaseb ® SPRAY

Manufacturer
Elanco US Inc. | Lab Express International | Yung Zip Chemical Industrial Co., Ltd. | Tropichem Research Labs, LLC dba Vetio
Effective date
2021-03-17
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:48:46

Label at a glance#

ProductMalaseb
Active ingredientChlorhexidine Gluconate, Miconazole
Label structure9 sections

Dosage and administration

Use in a well-ventilated area. Spray directly on the affected area(s) 2 to 3 times daily, as directed by your veterinarian. Do not allow animal to lick the treated areas until dry to prevent ingestion.

Storage and handling

Store at room temperature. Protect from freezing. Keep away from extreme heat or flame. Manufactured for Elanco US Inc. Shawnee, KS 66216 Malaseb is a registered trademark of Dermcare-Vet Pty. Ltd. © 2020 Elanco or its affiliates

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Topical spray formulation for dogs, cats and horses

CAUTION:

SPL UNCLASSIFIED SECTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

KEY INGREDIENTS:

SPL UNCLASSIFIED SECTION

Miconazole 1.74% w/v (equivalent to 2% w/v Miconazole Nitrate), Chlorhexidine Gluconate 2% w/v. Also contains Alcohol 30% w/v.

PRODUCT DESCRIPTION:

DESCRIPTION SECTION

Malaseb® Spray combines miconazole nitrate and chlorhexidine gluconate with the benefits of essential fatty acids and Vitamin E for skin barrier support and hydration.

INDICATIONS:

INDICATIONS & USAGE SECTION

For skin conditions responsive to miconazole nitrate and chlorhexidine gluconate. A convenient spray for easy spot application.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Use in a well-ventilated area. Spray directly on the affected area(s) 2 to 3 times daily, as directed by your veterinarian.

Do not allow animal to lick the treated areas until dry to prevent ingestion.

CAUTIONS:

SPL UNCLASSIFIED SECTION

For topical use on dogs, cats and horses. Do not allow animal to directly inhale the spray. 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.

STORAGE:

STORAGE AND HANDLING SECTION

Store at room temperature. Protect from freezing.

Keep away from extreme heat or flame.

Manufactured for Elanco US Inc.

Shawnee, KS 66216

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

© 2020 Elanco or its affiliates

Principal Display Panel – 237 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Elanco™

Malaseb®

SPRAY

Topical spray formulation
for dogs, cats and horses

2% w/v Chlorhexidine Gluconate

2% w/v Miconazole Nitrate

CAUTION: Federal law restricts this drug to use by
or on the order of a licensed veterinarian.

WARNING: Keep out
of reach of children.

Topical Spray

NET CONTENTS 237 mL (8 fl oz)

Principal Display Panel – 237 mL Bottle Label
Principal Display Panel – 237 mL Bottle Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58198-001058198-0010-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATEPAI Holdings, LLC dba PAI Pharmad3c2d8a7-bad5-410f-af83-e78a45e4b93f2026-08-25Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEMedline Industries, LP92eddf00-7e23-4d5b-b5cd-38af99ad9e562026-08-19Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATESage Products LLCbdb6a012-37e5-4664-84a3-134bea2847442026-06-16WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Sponge with 4% w/w chlorhexidine gluconate (CHG)CHLORHEXIDINE GLUCONATEXinxiang Xinda Technology Co.,Ltd53f4dd22-e4ab-5d8a-e063-6294a90a8c392026-06-11WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Swab Applicator Brushes 4% w/w chlorhexidine gluconate (CHG)CHLORHEXIDINE GLUCONATEXINXIANG XINDA TECHNOLOGY CO.,LTD51c1a74f-c6a8-b831-e063-6294a90a6c712026-05-24WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Swab Stick 2% w/w chlorhexidine gluconate (CHG)CHLORHEXIDINE GLUCONATEXINXIANG XINDA TECHNOLOGY CO.,LTD51c5a926-d137-9119-e063-6294a90a88452026-05-24WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Dyna-Hex 4CHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.0a32c299-f7ca-d15c-e063-6294a90af2c12026-04-30WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEMajor Pharmaceuticalsb48e69dc-0913-423f-e053-2a95a90a53df2026-04-29Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEBenco Dental21b03b2a-44ee-41c0-e054-00144ff8d46c2026-04-29Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Bactoshield CHGCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a6403ad-fa5e-2b4a-e054-00144ff8d46c2026-04-28WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a3a4cfe-88e0-0a10-e054-00144ff88e882026-04-27Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a9eda34-d85c-4b66-e054-00144ff88e882026-04-27WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a3a684f-5f72-347a-e054-00144ff8d46c2026-04-27Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
DYNA-HEX 2CHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.6cc89ac1-baef-40bb-85a3-d9ae9e3e7a632026-04-27WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEPreferred Pharmaceuticals, Inc.1c3401ef-6a7a-485e-ab7e-52420a36f4e22026-03-27Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
CleanCare Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATESafco Dental Supply LLC0d950be9-9d25-202c-e063-6294a90ada7d2026-03-02Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
CleanCare Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATESafco Dental Supply LLC0d9624f6-2a0b-c30f-e063-6294a90ae7172026-03-02Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%CHLORHEXIDINE GLUCONATEHenry Schein, Inc.4b0b50ef-78e1-5595-e063-6294a90aa84d2026-02-17WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%CHLORHEXIDINE GLUCONATEHenry Schein, Inc.4b0c6bcd-2242-f734-e063-6294a90a8fbf2026-02-17WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%CHLORHEXIDINE GLUCONATEHenry Schein, Inc.4b0d7b42-5757-6248-e063-6394a90a94c52026-02-17WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.