Label: MUPIROCIN ointment
- NDC Code(s): 51672-1354-0, 51672-1354-1, 51672-1354-2, 51672-1354-5
- Packager: Taro Pharmaceuticals U.S.A., Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated September 27, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- CAUTION
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DESCRIPTION
Each gram of mupirocin ointment contains 20 mg of mupirocin in a bland, water-washable ointment base consisting of polyethylene glycol 400 and polyethylene glycol 3350 (polyethylene glycol ointment). Mupirocin is a naturally-occurring, broad-spectrum antibiotic. The chemical name is 9-4-[5S-(2S,3S-epoxy-5S-hydroxy-4S-methylhexyl)-3R,4R-dihydroxytetrahydropyran-2S-yl]-3-methylbut-2(E)-enoyloxy-nonanoic acid. The chemical structure is:
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CLINICAL PHARMACOLOGY
Mupirocin is a chemical entity produced by fermentation of the organism Pseudomonas fluorescens. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase. Due to this mode of action, mupirocin shows no cross resistance with chloramphenicol, erythromycin, gentamicin, lincomycin, neomycin, novobiocin, penicillin, streptomycin, and tetracycline. Mupirocin is an antimicrobial agent that inhibits the growth of gram-positive and gram-negative bacteria.
Bacteria susceptible to the action of mupirocin in vitro include the aerobic isolates of Staphylococcus aureus (including methicillin-resistant strains and β-lactamase-producing strains), Staphylococcus intermedius, Staphylococcus epidermidis, other coagulase positive or negative Staphylococci, α-hemolytic Streptococci, β group A Streptococci (including S. pyogenes), other β Streptococci (including S. agalactiae), group D Streptococci (including S. faecalis and S. faecium), group Viridans Streptococci, Streptococcus pneumoniae, Corynebacterium hofmanii, Bacillus subtilis, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Enterobacter cloacae, Enterobacter aerogenes, Citrobacter freundii, Hemophilus influenzae (including β-lactamase-producing strains), Neisseria gonorrheae (including β-lactamase-producing strains), Neisseria meningitidis, Branhamella catarrhalis and Pasteurella multocida, and the anaerobic isolates of Peptostreptococcus anaerobius, Clostridium difficile, and Clostridium sporogenes.
Clinical significance of the in vitro data is unknown except for susceptible strains of Staphylcoccus aureus and Staphylococcus intermedius.
- INDICATIONS FOR USE
- CONTRAINDICATIONS
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WARNINGS
Because of the potential hazard of nephrotoxicity due to the polyethylene glycol content of the base, care should be exercised when using this product in treating extensive deep lesions where absorption of large quantities of polyethylene glycol is possible.
Safety of use in pregnant or breeding animals has not been determined.
Mupirocin ointment is not for ophthalmic use.
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 22 g Tube Carton
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INGREDIENTS AND APPEARANCE
MUPIROCIN
mupirocin ointmentProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:51672-1354 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Mupirocin (UNII: D0GX863OA5) (Mupirocin - UNII:D0GX863OA5) Mupirocin 20 mg in 1 g Inactive Ingredients Ingredient Name Strength polyethylene glycol 400 (UNII: B697894SGQ) polyethylene glycol 3350 (UNII: G2M7P15E5P) Product Characteristics Color WHITE (cream-like) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51672-1354-5 1 in 1 CARTON 1 5 g in 1 TUBE 2 NDC:51672-1354-1 1 in 1 CARTON 2 15 g in 1 TUBE 3 NDC:51672-1354-0 1 in 1 CARTON 3 22 g in 1 TUBE 4 NDC:51672-1354-2 1 in 1 CARTON 4 30 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200457 11/29/2010 Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE Establishment Name Address ID/FEI Business Operations Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd 654019884 API MANUFACTURE Establishment Name Address ID/FEI Business Operations Teva Pharmaceutical Works Private Limited Company 366709764 API MANUFACTURE Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE