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warnings and cautions
5 WARNINGS AND PRECAUTIONS • If signs of irritation occur, discontinue use. ( 5.1 ) • Avoid contact with eyes. ( 5.1 ) • Hair discoloration has been reported with Ciclopirox use. ( 5.1 ) 5.1 Local Effects If a reaction suggesting sensitivity or irritation occurs with the use of Ciclopirox Shampoo 1%, treatment should be discontinued and appropriate therapy instituted. Contact of Ciclopirox Shampoo 1% with the eyes should be avoided. If contact occurs, rinse thoroughly with water. In patients with lighter hair color, hair discoloration has been reported.
6 ADVERSE REACTIONS • The most frequently reported adverse reactions are pruritus, burning, and erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fougera Pharmaceuticals Inc. at 1-800-645-9833 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 clinical practice. In 626 subjects treated with Ciclopirox Shampoo twice weekly in the two pivotal clinical trials, the most frequent adverse events were increased itching in 1% of subjects, and application site reactions, such as burning, erythema, and itching, also in 1% of subjects. 6.2 Post Marketing Experience The following adverse reactions have been identified during post approval use of Ciclopirox Shampoo 1%: hair discoloration and abnormal hair texture, alopecia, irritation and rash. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.