determine irritation potential - a test article on the external
genitalia of women under actual use conditions.
Start within 2 weeks of the time the test material is received
assessment by a Board Certified Gynecologist
individual containers with enough product to last for at least 2 weeks
actual use conditions
Safe for intended use
study day 1, the Medical Investigator (a Board-Certified Gynecologist)
examines the external genitalia of approximately 30 subjects to determine
their eligibility for the study. Enrolled subjects are then given
the product to use at home for 2 weeks, use instructions and a daily
diary to record time of usage as well as any other significant comments.
After one week subjects call the testing facility. After 2 weeks,
they return for a follow-up exam by the Gynecologist.