A Pharmacokinetics (PK) Study in Lice Infested Children 6 Months to 3 Years of Age

Exclusion Criteria

• •Subjects who have received any OTC or prescription treatment for head lice in the last 2 weeks.
• •Subjects or subjects' caregivers who are unable to comply with the study obligations and all study visits.
• •Subjects whose caregivers do not understand the requirements for participation and/or may be likely to exhibit poor compliance, in the opinion of the Investigator.
• •Subjects with eczema, atopic dermatitis, or other chronic conditions of the scalp and skin.
• •Subjects with visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is \> 2, blisters, or any other condition that, in the opinion of the investigative personnel or Sponsor, would interfere with the PK, safety and/or efficacy evaluations.
• •Subjects with a history of allergy to ivermectin or any ingredients commonly included in hair products such as shampoos, hair conditioners, or styling aids.
• •Subjects with other diagnoses that, in the opinion of the Investigator, would interfere with the PK, safety, and/or efficacy assessments or would preclude study participation.
• •Subjects who have been treated with a systemic antibiotic within 2 weeks before screening.
• •Subject currently taking warfarin sodium (Coumadin®) or has taken within 2 weeks before screening.
• •Subjects who have been enrolled in any clinical study within the past 30 days; subjects may not participate in another study while participating in this study.