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)].