FDA label 2e71e69d-2712-4d41-8946-880bb22e5bdc

5 WARNINGS AND PRECAUTIONS Severe Allergic Reactions: Including anaphylaxis, urticaria, angioedema, and generalized rash have been reported in patients treated with CENTANY ® ointment. ( 5.1 ) Eye and Nose Irritation: Not intended for ophthalmic use or nasal use or on mucosal surfaces. ( 5.2 ) Local Irritation: If signs of sensitivity or irritation should occur, treatment should be discontinued. ( 5.3 ) Clostridium difficile -associated Diarrhea (CDAD): If diarrhea occurs, evaluate patients for CDAD. ( 5.4 ) Potential for Microbial Overgrowth: Prolonged use may result in overgrowth of nonsusceptible microorganisms, including fungi. ( 5.5 ) 5.1 Severe Allergic Reactions Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash have been reported in patients with mupirocin formulations. [see Adverse Reactions (6.2) ] . 5.2 Eye and Nose Irritation CENTANY ® ointment is not for ophthalmic use or nasal use or on mucosal surfaces. If this product comes in contact with the eyes, rinse thoroughly with water. 5.3 Local Irritation If a reaction suggesting sensitivity or chemical irritation should occur with the use of CENTANY ® ointment treatment should be discontinued and appropriate alternative therapy for the infection instituted. 5.4 Clostridium difficile -associated Diarrhea Clostridium difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. 5.5 Potential for Microbial Overgrowth As with other antibacterial products, prolonged use of CENTANY ® ointment may result in overgrowth of nonsusceptible microorganisms, including fungi [see Dosage and Administration (2) ] .

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Systemic Allergic Reactions [see Warnings and Precautions (5.1) ] Eye and Nose Irritation [see Warnings and Precautions (5.2) ] Local Irritation [see Warnings and Precautions (5.3) ] Clostridium difficile -associated Diarrhea [see Warnings and Precautions (5.4) ] Most common adverse reactions (≥0.3%) are application site reactions, pruritus, contact dermatitis, furunculosis, exfoliative dermatitis and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following local adverse reactions have been reported in connection with the use of CENTANY ® ointment, in 300 patients in one clinical trial: application site reactions and pruritus, each in 1% of patients; contact dermatitis and furunculosis, each in 0.7% of patients; and exfoliative dermatitis and rash, each in 0.3% of patients. 6.2 Post Marketing Experience The following local adverse reactions have been identified during post-approval use of CENTANY ® ointment. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash [see Warnings and Precautions (5.1) ].