FDA.reportPublic FDA data

Mal-A-Ket

Manufacturer
Dechra Veterinary Products
Effective date
2023-12-12
Label type
OTC ANIMAL DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:42:39

Label at a glance#

ProductMal-A-Ket
Active ingredientCHLORHEXIDINE GLUCONATE, KETOCONAZOLE
Label structure8 sections

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

VETERINARY INDICATIONS SECTION

For support of healthy skin for animals with conditions responsive to ketoconazole and/or chlorhexidine.

DESCRIPTION SECTION

Active Ingredients: 2% Chlorhexidine Gluconate, USP; 1% Ketoconazole, USP

Also Contains: Water, Lauramine Oxide, Polyacrylate-1 Crosspolymer, Cocamidopropyl Betaine, Decyl Polyglucoside, Acetic Acid, Fragrance, Sodium Hydroxide, Tetrasodium EDTA, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone

DOSAGE & ADMINISTRATION SECTION

Directions for Use: SHAKE WELL BEFORE EACH USE. Apply to wet coat, rub onto skin and haircoat to create a rich lather. Allow shampoo to remain on skin and coat for 5-10 minutes. Rinse well. Use initially 2-4 times per week for 4 weeks, then reduce to once per week or as directed by veterinarian.

SAFE HANDLING WARNING 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.

WARNINGS 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.

SPL UNCLASSIFIED SECTION

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

MKW REV08/23-C

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHAKE WELL BEFORE USING

Mal-A-Ket®

Shampoo
2% Chlorhexidine Gluconate, USP
1% Ketoconazole, USP

Formulated for dogs, cats
and horses

Antimicrobial, antifungal

U.S. Patent
9,345,674

8 fl. oz. (236 mL)

Dechra

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1424016chlorhexidine gluconate 2 % / ketoconazole 1 % Medicated ShampooPSN2
1424016chlorhexidine gluconate 20 MG/ML / ketoconazole 10 MG/ML Medicated ShampooSCD2
1424016chlorhexidine gluconate 2 % / ketoconazole 1 % Medicated ShampooSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORHEXIDINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
KETOCONAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17033-131-01Mal-A-Ket3785 mL in 1 BOTTLESHAMPOO, SUSPENSION37852
17033-131-08Mal-A-Ket236 mL in 1 BOTTLESHAMPOO, SUSPENSION2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17033-131MAL-A-KET (CHLORHEXIDINE GLUCONATE AND KETOCONAZOLE) SHAMPOO, SUSPENSION [DECHRA VETERINARY PRODUCTS]22 package rows20231214_7efb50d9-6395-40e8-a65b-a37e45d90469.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17033-13117033-131-08, 17033-131-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORHEXIDINE GLUCONATEMOR84MUD8EACTIB
KETOCONAZOLER9400W927IACTIB

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.