TODAY VAGINAL CONTRACEPTIVE- nonoxynol-9 sponge
Mayer Laboratories, Inc.
Some cases of Toxic Shock Syndrome (TSS) have been reported in women using barrier contraceptives, including the sponge. TSS is a rare, but serious disease that may cause death. Warning signs of TSS include fever, nausea, vomiting, diarrhea, muscle pain, dizziness, faintness or a sunburn-like rash on face or body. If you have any of these signs, remove the sponge and get medical help right away
This product does not protect against HIV/AIDS or other STDs and may increase the risk of getting HIV from an infected partner
benzoic acid, citric acid, sodium dihydrogen citrate, sodium metabisulfite, sorbic acid, water in a polyurethane foam sponge.
Vaginal Contraceptive Sponge
This 24-hour vaginal contraceptive sponge is intended for the prevention of pregnancy.
Consumer Information Leaflet
Your Personal Guide
Please read the Drug Facts label on the carton and this leaflet completely and carefully before using Today® Sponge. If used correctly according to the label and diagram instructions on back of leaflet, Today® Sponge may be a safe, effective and convenient birth control method.
IMPORTANT INFORMATION FOR USERS
If you have no previous experience with vaginal birth control products, you should contact a doctor, health professional or family planning clinic for advice on how to use this product correctly. If you have any questions on the best birth control method for you, contact a doctor, health professional or a family health clinic, especially if:
No birth control product can prevent pregnancy all the time. See Table of Pregnancy Rates for Birth Control Methods for a comparison of pregnancy rates.
No birth control method is without side effects or is suitable for all women. Consult a health professional for your best method.
For best results, barrier methods, such as the sponge or condom, must be used correctly during every act of intercourse.
Pregnancy Rates for Birth Control Methods
(For One Year of Use)
In clinical studies with Today® Sponge, the pregnancy rates per 100 women during the first year of use were:
The following table gives the approximate number of women out of 100 women who are likely to become pregnant while using a particular contraceptive method for one year.
Pregnancy Rates for Birth Control Methods
Number of Women Out of 100 Women Who Will Become Pregnant in the First Year of Use
|Method||Number of women out of 100 who will become pregnant in one year of typical use*|
||Less than 1|
||Less than 1|
||25 - 27|
Data adapted from: Trussell J. Contraceptive Efficacy. In Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology: Nineteenth Revised Edition. New York, NY: Ardent Media, 2007.
|1. PRODUCT OVERVIEW|
A. What is Today Vaginal Contraceptive Sponge and how does it work?
This birth control product is a soft, disposable polyurethane foam sponge containing 1000 mg of nonoxynol 9, which kills sperm on contact. It is inserted into the vagina and while in place provides protection against pregnancy for 24 hours. As long as the sponge is in place in the vagina, there is no need to add additional spermicidal creams or jellies, even if intercourse is repeated.
Used as directed, Today® Sponge prevents pregnancy in three ways: 1) the nonoxynol 9 contained in Today® Sponge kills sperm before they can reach the egg; 2) Today® Sponge blocks the cervix opening to the uterus so the sperm cannot enter; 3) Today® Sponge traps and absorbs the sperm.
B. How can I improve the effectiveness of the Today Vaginal Contraceptive Sponge?
No birth control method can provide reliable protection if it is not used correctly and consistently.
For greater birth control protection, you may want to use another method of birth control in addition to using the sponge, especially during the first few months while you become familiar with how to use it.
Correct use of a latex condom by your partner together with your correct use of the Today® Sponge may provide additional protection against getting pregnant.
C. How easy is it to use Today Vaginal Contraceptive Sponge?
This product is designed to be convenient and easy to use, and to avoid interruption of lovemaking, because it can be inserted up to 24 hours before starting intercourse. Protection begins right away and lasts for 24 hours even with repeated acts of intercourse. However the sponge should remain in place for at least 6 hours after the last act of intercourse, but should not be left in the vagina longer than 30 hours.
Any woman who can use a tampon should not have difficulty using the sponge. It does not require a special fitting or prescription.
Toxic Shock Syndrome: Some cases of Toxic Shock Syndrome (TSS) have been reported in women using barrier contraceptives, including the sponge. TSS is a rare, but serious disease that may cause death. Warning signs of TSS include fever, nausea, vomiting, diarrhea, muscle pain, dizziness, faintness or a sunburn-like rash on face or body. If you have any of these signs, remove the sponge and get medical help right away. You can avoid the risk of getting sponge-associated TSS by not using the sponge
Sexually transmitted diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDs and may increase the risk of getting HIV from an infected partner
Do not use
Ask a doctor before use if you have
When using this product
Stop use and ask a doctor if
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (For most people, ingestion of small quantities of spermicide alone should not be harmful.)
Before using, read the back of this leaflet for diagram instructions for inserting and removing sponge.
Douching is not necessary. If you want to douche wait at least 6 hours after last intercourse and remove the sponge before douching.
|4. INACTIVE INGREDIENTS|
Benzoic acid, citric acid, sodium dihydrogen citrate, sodium metabisulfite, sorbic acid, water in a polyurethane foam sponge.
|5. OTHER INFORMATION|
|6. OTHER QUESTIONS YOU MAY HAVE|
A. How can I reduce the chances of a serious infection including sexually transmitted diseases (STDs)?
B. Can I use Today® Sponge during my menstrual period?
C. Can I have an allergic reaction or other side effects from the Today® Sponge?
D. What if Today® Sponge develops an odor?
E. Can I insert Today® Sponge after intercourse?
F. How does Today® Sponge stay in place? Can the sponge get lost in my body?
G. Can Today® Sponge tear while it is in place?
H. What if I have trouble removing Today® Sponge?
I. Can my partner feel Today® Sponge during intercourse?
J. Can I leave Today® Sponge in place when I swim or bathe?
K. Is Today® Sponge as effective as the pill or IUD?
L. Can I use Today® Sponge more than once?
Additional questions or comments?
Call toll free1-877-494-2525 M-F 8am-5pm PST
|7. Important Points to Remember|
|8. Some basic information about your reproductive system|
|A. To use this method effectively, it is important for you to understand your anatomy.||B. How do I find the vaginal opening?|
|Today Vaginal Contraceptive Sponge is inserted through the vaginal opening and placed in the deepest part of the vagina, just below the cervix. The cervix is at the bottom end of the uterus, and has a small opening through which sperm must travel to reach and fertilize the egg.||Sit on the edge of a chair with knees apart. Place a good source of light about an arm's length in front of you and use a hand mirror to examine the region between the outer "lips," or labia. The vaginal opening is between the labia, just below the small urinary opening and one or two inches below the clitoris.|
|C. How do I find the cervix?||D. Bearing Down|
|It is easier to find the cervix if you squat. Insert your finger gently into the vagina, reaching up on an angle toward the back until you find the firm, round surface of the cervix. It feels something like the tip of your nose. In some cases, it may be difficult to locate, so you may have to explore a bit before you find it.||You can bring your cervix down closer to the vaginal opening, and thus make it easier to locate, by bearing down. Take a deep breath and bear down as if you were having a bowel movement. You should now be able to locate your cervix just above the vaginal opening. This technique is also very useful for removing the sponge.|
|9. How to insert Today Vaginal Contraceptive Sponge|
A. Insertion Procedure
The sponge may be inserted any time up to 24 hours before intercourse.
B. Questions about insertion of Today® Sponge.
1. How do I know Today® Sponge is in the proper position?
If you follow the instructions in this booklet, Today® Sponge should be positioned correctly in the upper vagina. To check its position, simply slide your finger around the edge of the sponge. If your cervix is not exposed, the sponge is in the proper position. You should be able to feel the string loop. If the sponge is out of position, simply slide it back in place.
2. Can Today® Sponge fall out?
It is unlikely that Today® Sponge will fall out. During a bowel movement or other form of internal straining, it may be pushed down to the opening of the vagina and perhaps fall out. If you suspect this happening, simply insert your finger into your vagina and push it back. If it should fall into the toilet, moisten a new sponge and insert it immediately. Do not flush the old sponge down the toilet. Discard it in a waste container.
3. How does Today® Sponge stay in place?
Today® Sponge is held in place by the muscles of the upper vagina. In addition, the cup-like indentation on the top of the sponge helps to keep it in position directly over the cervix.
|10. How to remove Today Vaginal Contraceptive Sponge|
A. Removal Procedure
|2. Put your finger into your vagina and reach up and back to find the string loop. If you cannot find the loop immediately, bear down until you feel the loop (see "Bearing Down," section 8D). Hook your finger around the loop. (If you have not found the loop, grasp the sponge between your thumb and forefinger.)|
|3. Slowly and gently pull the sponge out. If the vaginal muscles seem to be holding it tightly, wait a few minutes and try again. If removal is still difficult, use the following exercise to relax your vaginal muscles: Tighten vaginal muscles as hard as you can and hold for 10 seconds, then relax and let go. Repeat. As you relax, breathe out slowly while bearing down (see section 8D). Now remove the sponge as you continue to relax.|
B. Special Removal Situations
1. Stuck Sponge
There are no structures in the vagina to interfere with removal of the sponge. With tension or unusually strong muscular pressure, the sponge may be held in the vagina more tightly than normal. Simple relaxation of the vaginal muscles and bearing down should make it possible to remove the sponge without difficulty (see section 8D).
If you are still unable to remove the sponge, it may have adhered by suction to the cervix. To remove, it is necessary to break the suction. To do this, slip a finger between the sponge and the cervix on one side, tilting the sponge up and away from the cervix. Once free, the sponge may be removed normally.
If none of the above suggestions seems to help, see your physician or family planning clinic. You may wish to take several unused Today® Sponges along so your medical advisor can help you refine your insertion and removal technique.
2. Upside-down Sponge
|Occasionally, a sponge will turn upside down in the vagina, making the string loop more difficult to find. To find the string loop, run your finger around the edge on the back side of the sponge until you feel the string loop where it's attached to the sponge.|
|If you cannot find the string loop, simply grasp the edge of the sponge between your thumb and forefinger and pull it out slowly. Bearing down (section 8D) will make it easier to reach the sponge.|
3. Torn Sponge
Today® Sponge, like a soft contact lens, should be handled gently. Pulling too hard or too quickly on the removal loop may cause the sponge to tear.
|The procedure for removing a torn sponge is similar to that for an upside-down sponge. The important thing is to remove the sponge slowly. If you suspect that you have left small pieces of sponge inside the vagina, run a finger around the upper vault of your vagina with a sweeping movement and then toward the vaginal opening to find and remove any remaining sponge material. To reduce the risk of infection, it is important that you get all parts of sponge out of the vagina. If you have difficulty getting parts of sponge out of the vagina, call the Mayer Labs Product Support Line at 1-877-494-2525 or contact a health professional right away.
C. Questions about removal of Today® Sponge.
1. Is it necessary to douche after removing Today® Sponge?
No, it is not necessary. However, you may douche after using the sponge if you like. But do not douche while the sponge is inside the vagina. And always wait at least 6 hours after intercourse before removing the sponge.
2. Can Today® Sponge get lost in my body?
The opening from the vagina to the uterus is far too small for Today® Sponge to pass through. There is no other normal opening in the vagina that would provide access to any other part of your body.
Mayer Laboratories, Inc.
1950 Addison Street, Berkeley, CA 94704, USA
www.TodaySponge.com / 1-877-494-2525
Today is a registered trademark
of Almatica Pharma, Inc.
Made in U.S.A
© 2011 Mayer Laboratories, Inc
|TODAY VAGINAL CONTRACEPTIVE
|Labeler - Mayer Laboratories, Inc. (175425982)|