Results from clinical trials.1-3

When applied on the outer layer of the epidermis, the active compound (spinosad) is absorbed into the stratum corneum (but not beyond) before sloughing off through the natural process of non-pathologic desquamation (over approximately 14 days).1,5

Chart documenting adverse reactions

*Application site irritation also includes application site pain and burning sensation
**Trial 3 (Proof-of-Concept Study) was a randomized, double-blind, vehicle-controlled study to assess the effect of Spinosad Topical Suspension 0.9% on the treatment of scabies

No systemic absorption

Systemic absorption of the active compound, spinosad, is below the level of quantitation (3 ng/mL), even in patients as young as five (5) years of age.2

No toxicities

There is no evidence of neurotoxicity, developmental/ reproductive toxicity, immunotoxicity, mutagenicity, or carcinogenicity from exposure to the active compound, spinosad.1

No lab abnormalities

A review of the individual and summary laboratory test results did not identify any clinically significant safety signals with the active compound, spinosad.1

A proven therapy for pediatric patients 4 years of age and older.2

Prescription data indicates that 29% of all scabies prescriptions in the US are for children under the age of 18 years.3 The safety and efficacy of Spinosad Topical Suspension 0.9% have been established in pediatric patients (165) who are four (4) years of age and older.1-3