Docket Management
Docket: 80N-0280 - Over-the-Counter Vaginal Contraceptive Drug Products Containing Nonoxynol 9; Required Labeling
Comment Number: EC -1

Accepted - Volume 14

Comment Record
Commentor Dr. Donald Hicks Date/Time 2003-01-18 13:07:55
Organization LA City College
Category Academic

Comments for FDA General
1. General Comments Sirs: I have done in-vitro research with these spermicidal products. Please note the following comments (1) Octoxynol-9 and 10 are essentially the same product found in the over-the-counter diaphragm gel product ORTHOGYNOL and should be treated the same as N-9 (2) The most significant factor relating to the danger of STD infection due to detergent (spermicides such as N-9 and 0-9) use is - over doseage and repeated daily use!!!! (3) The amount of N-9 contained in the current markedted condoms as lubricant is insignificant to this issue

EC -1