Label: MAL-A-KET- chlorhexidine gluconate, acetic acid, and ketoconazole solution
- NDC Code(s): 17033-132-01, 17033-132-08
- Packager: Dechra Veterinary Products
- Category: OTC ANIMAL DRUG LABEL
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Drug Label Information
Updated February 26, 2021
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- VETERINARY INDICATIONS
- DESCRIPTION
- DOSAGE & ADMINISTRATION
- SAFE HANDLING WARNING
- WARNINGS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
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INGREDIENTS AND APPEARANCE
MAL-A-KET
chlorhexidine gluconate, acetic acid, and ketoconazole solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:17033-132 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 20 mg in 1 mL ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P) ACETIC ACID 20 mg in 1 mL KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength LAURAMINE OXIDE (UNII: 4F6FC4MI8W) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) EDETATE SODIUM (UNII: MP1J8420LU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17033-132-01 3785 mL in 1 BOTTLE 2 NDC:17033-132-08 236 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 04/01/2012 Labeler - Dechra Veterinary Products (362142734) Establishment Name Address ID/FEI Business Operations Unilab Chemical and Pharmaceuticals Private Limited 915893696 API MANUFACTURE Establishment Name Address ID/FEI Business Operations Piramal Enterprises Limited 919067108 API MANUFACTURE Establishment Name Address ID/FEI Business Operations Sharon Bio-Medical Limited 675472749 API MANUFACTURE