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warnings and cautions
5 WARNINGS AND PRECAUTIONS Benzyl alcohol toxicity: Not recommended in infants below the age of 6 months; potential for increased systemic absorption. ( 5.1 ) 5.1 Benzyl Alcohol Toxicity Spinosad Topical Suspension contains benzyl alcohol and is not recommended for use in neonates and infants below the age of 6 months. Systemic exposure to benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants [See Use in Specific Populations (8.4) ] .
6 ADVERSE REACTIONS Most common adverse events (>1% ) were application site erythema and ocular erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Macoven Pharmaceuticals at 1-877-622-6836 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. Spinosad Topical Suspension was studied in two randomized, active-controlled trials (N=552) in subjects with head lice; the results are presented in Table 1. Table 1: Selected Adverse Events Occurring in at least 1% of Subjects Signs Spinosad 0.9% (N=552) Permethrin 1% (N=457) Application site erythema 17(3%) 31(7%) Ocular erythema 12 (2%) 15 (3%) Application site irritation 5 (1%) 7 (2%) Other less common reactions (less than 1% but more than 0.1%) were application site dryness, application site exfoliation, alopecia, and dry skin. Systemic safety was not assessed in pediatric subjects under 4 years of age as laboratory parameters were not monitored in these controlled studies.