Spinosad

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 approved 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 when administered intravenously [See Use in Specific Populations (8.4) ] .

6 ADVERSE REACTIONS Most common adverse events for lice treatment (>1%) were application site erythema and ocular erythema. ( 6.1 ) Most common adverse reactions for scabies treatment (>1%) were application site irritation (pain and burning) and dry skin. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Allegis Pharmaceuticals, LLC at 1-866-633-9033 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. Head Lice Infestations Spinosad Topical Suspension was studied in two randomized, active-controlled trials (N=552) in subjects with head lice; Table 1 presents selected adverse events, regardless of relationship to Spinosad Topical Suspension, that occurred in at least 1% of subjects. Table 1: Selected Adverse Events Occurring in at least 1% of Subjects with Head Lice Infestation Signs Spinosad (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. Scabies Infestations Spinosad Topical Suspension was studied in three randomized, double-blind, vehicle-controlled trials (Trial 1, Trial 2, and Trial 3) in 592 subjects with scabies infestation, of which 165 were ages 4-17 and 427 were adults. Subjects received a single application of Spinosad Topical Suspension to the skin from the neck to the soles of the feet, which was washed off after a minimum of 6 hours. Table 2 presents adverse reactions related to Spinosad Topical Suspension treatment that occurred in at least 1% of subjects. Table 2: Adverse Reactions Occurring in at least 1% of Subjects with Scabies Infestation (Trials 1, 2 and 3) Signs Spinosad (N=322) Vehicle (N=270) Application site irritation Application site irritation also includes application site pain and burning sensation. 8 (3%) 0 (0%) Dry skin 6 (2%) 0 (0%)

<table width="70%"><caption>Table 1: Selected Adverse Events Occurring in at least 1% of Subjects with Head Lice Infestation</caption><col width="34%" align="left" valign="top"/><col width="33%" align="center" valign="top"/><col width="33%" align="center" valign="top"/><thead><tr><th align="center" styleCode="Lrule Rrule">Signs</th><th styleCode="Rrule">Spinosad (N=552)</th><th styleCode="Rrule">Permethrin 1% (N=457)</th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Application site erythema</td><td styleCode="Rrule">17 (3%)</td><td styleCode="Rrule">31(7%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Ocular erythema</td><td styleCode="Rrule">12 (2%)</td><td styleCode="Rrule">15 (3%)</td></tr><tr><td styleCode="Lrule Rrule">Application site irritation</td><td styleCode="Rrule">5 (1%)</td><td styleCode="Rrule">7 (2%)</td></tr></tbody></table>

<table width="70%"><caption>Table 2: Adverse Reactions Occurring in at least 1% of Subjects with Scabies Infestation (Trials 1, 2 and 3)</caption><col width="34%" align="left" valign="top"/><col width="33%" align="center" valign="top"/><col width="33%" align="center" valign="top"/><thead><tr><th align="center" styleCode="Lrule Rrule">Signs</th><th styleCode="Rrule">Spinosad (N=322)</th><th styleCode="Rrule">Vehicle (N=270)</th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Application site irritation <footnote ID="K799">Application site irritation also includes application site pain and burning sensation.</footnote></td><td styleCode="Rrule">8 (3%)</td><td styleCode="Rrule">0 (0%)</td></tr><tr><td styleCode="Lrule Rrule">Dry skin</td><td styleCode="Rrule">6 (2%)</td><td styleCode="Rrule">0 (0%)</td></tr></tbody></table>