Spinosad

2 DOSAGE AND ADMINISTRATION For topical use only. Not for oral, ophthalmic, or intravaginal use. 1 Important Administration Instructions For topical use only. Spinosad Topical Suspension is not for oral, ophthalmic, or intravaginal use.

Avoid contact with eyes. If Spinosad Topical Suspension gets in or near the eyes, rinse thoroughly with water. 2 Treatment of Head Lice Infestations Shake bottle well. Apply a sufficient amount of Spinosad Topical Suspension to cover dry scalp, then apply to dry hair.

Depending on hair length, apply up to 120 mL (one bottle) to adequately cover scalp and hair. Leave on for 10 minutes, then thoroughly rinse off with warm water. Wash hands after use. If live lice are seen 7 days after the first treatment, a second treatment should be applied.

1) ]. 3 Treatment of Scabies Infestations Shake bottle well. Apply a sufficient amount of Spinosad Topical Suspension to skin to completely cover the body from the neck to the toes (including the soles of the feet). For patients with balding scalp, also apply product to the scalp, hairline, temples, and forehead.

Allow to absorb into the skin and dry for 10 minutes before getting dressed. Leave on the skin for at least 6 hours before showering or bathing. Apply Spinosad Topical Suspension on pediatric patient only under direct supervision of an adult .

6 ADVERSE REACTIONS Most common adverse events for lice treatment (>1%) were application site erythema and ocular erythema. 1 ) Most common adverse reactions for scabies treatment (>1%) were application site irritation (pain and burning) and dry skin.

gov/medwatch. 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.

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%)

5 WARNINGS AND PRECAUTIONS Benzyl Alcohol Toxicity: Not recommended in infants below the age of 6 months; potential for increased systemic absorption. 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.

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4 CONTRAINDICATIONS None. None. ( 4 )