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Animal NDC 17033-420-15 Muricin

Mupirocin

Animal Product Information

Field Name Field Value
Animal NDC Code 17033-420-15
Proprietary Name Muricin What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Mupirocin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Dechra Veterinary Products
Product Type Prescription Animal Drug
Usage Information
    Muricin ointment is indicated for the topical treatment of canine bacterial infections of the skin, including superficial pyoderma, caused by susceptible strains of Staphylococcus aureus and Staphylococcus intermedius.
Active Ingredient(s)
  • Mupirocin
Inactive Ingredient(s)
  • POLYETHYLENE GLYCOL 3350 (G2M7P15E5P)
  • POLYETHYLENE GLYCOL 400 (B697894SGQ)
  • POLYETHYLENE GLYCOL 3350 (G2M7P15E5P)
  • POLYETHYLENE GLYCOL 400 (B697894SGQ)
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200418 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Muricin Images

Muricin Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



For dermatologic use on dogs.

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


Description:



Each gram of Muricin 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, NF). Mupirocin is a naturally-occurring, broadspectrum antibiotic. The chemical name is (E)-(2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The chemical structure is:


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 Staphylococcus aureus and Staphylococcus intermedius.


Indications For Use:



Muricin ointment is indicated for the topical treatment of canine bacterial infections of the skin, including superficial pyoderma, caused by susceptible strains of Staphylococcus aureus and Staphylococcus intermedius.


Contraindications:



This drug is contraindicated in animals with a history of sensitivity reactions to any of its components.


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. Muricin ointment is not for ophthalmic use.

Adverse Reactions:



No adverse reactions have been reported with this product. If a skin reaction such as irritation should occur, treatment should be discontinued and appropriate therapy instituted.

To report suspected adverse drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet, contact Dechra Veterinary Products at (866) 933-2472.

  •  For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

Dosage And Administration:



  •  Prior to treatment, the lesion should be cleansed. Muricin ointment should be applied to the affected area twice a day. Apply a sufficient amount of ointment to completely cover the infected area. Maximum duration of treatment should not exceed 30 days.

How Supplied:



  •  Muricin ointment is supplied in 15-gram tubes.

    • NDC 17033-420-15.

    Store between 15° and 30°C (59° and 86°F).

    Keep out of reach of children.


Important:



The opening of this product is covered by a metal tamper-evident seal.

If this seal has been punctured or is not visible, do not use and return product to place of purchase.

Approved by FDA under ANADA # 200-418

Manufactured for:

Dechra Veterinary Products

Overland Park, KS 66211 USA

Manufactured by:

Fougera Pharmaceuticals Inc.

Melville, NY 11747 USA

46269504

Rev. December 2022


Principal Display Panel - 15 G Carton



Muricin®
(mupirocin ointment) 2%
For dermatologic use on dogs
NET WT 15 g
NDC 17033-420-15


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.