Gynecologic Safety
Outline: Gynecologic Safety-In-Use
Objective:

To determine irritation potential - a test article on the external genitalia of women under actual use conditions.

Subjects:

30 healthy volunteers

Timing:

2-week test
Start within 2 weeks of the time the test material is received

Quantity: Clinical assessment by a Board Certified Gynecologist

Methodology:
35 individual containers with enough product to last for at least 2 weeks actual use conditions
Claims:

Gynecologist Tested
Safe for intended use

Procedures:
On 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.