Drug Facts
Drug Facts
Drug Facts
Purpos e
Vaginal contraceptive
Us e
Prevents pregnancy
Warnings
For vaginal us e only
Not for rectal (anal) us e
Do not us e
within the first six weeks after giving birth
if you have ever had Toxic Shock Syndrome
during your menstrual period
if you or your sex partner has HIV/AIDS. If you do not know if you or your sex partner is infected,
choose another form of birth control
if you are allergic to sulfites. This product contains sodium metabisulfite which may cause severe
allergic reactions in some people
if you have ever had an allergic reaction to nonoxynol 9 or to this product
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right
away.
Directions
before using, read enclosed consumer information leaflet for complete directions and information
wet the sponge thoroughly with clean water, squeeze gently until sponge is very sudsy
with the dimple side inside, fold sponge. With string loop on bottom end, insert the sponge deep into
the vagina (see diagram in enclosed leaflet)
protection begins right away and lasts for 24 hours even with repeated acts of intercourse
wait 6 hours after last intercourse before removing sponge
do not leave s ponge in vagina for longer than 30 hours
do not re-us e the s ponge
if you have trouble removing or remove only part of the sponge from vagina, contact the Mayer
Labs Product Support Line (1-877-494-2525) or a health professional right away
Other information
in clinical studies about 1 out of 10 women (9-11%) got pregnant during the first year of use when
using this product correctly all the time. The possibility of getting pregnant increases to about 1 out
of 7 women (13-16%) when this product was not used correctly
studies have raised safety concerns that products containing the spermicide nonoxynol 9 can irritate
the vagina and rectum. Sometimes this irritation has no symptoms. This irritation may increase the
risk of getting HIV/AIDS from an infected partner
you can use nonoxynol 9 for birth control with or without a condom if you have sex with only one
partner who is not infected with HIV and who has no other sexual partners or HIV risk factors
when used correctly every time you have sex, latex condoms greatly reduce, but do not eliminate,
the risk of catching or spreading HIV, the virus that causes AIDS
use a latex condom without nonoxynol 9 if you or your sex partner has HIV/AIDS, multiple sex
partners, or other HIV risk factors
ask a health professional if you have questions about your best birth control and STD prevention
methods
store at 20-25°C (68-77°F)
Inactive ingredients
benzoic acid, citric acid, sodium dihydrogen citrate, sodium metabisulfite, sorbic acid, water in a
polyurethane foam sponge.
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:
About 1 out of 10 women (9-11%) became pregnant when using this correctly all the time.
The possibility of getting pregnant increased to about 1 out of 7 women (13-16%) when this product
was not used correctly.
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 Firs t Year of Us e
Table A
Number of
Mos t women out of
Effective 100 who will
(Fewer Method become
Pregnancies ) pregnant in
one year of
one year of
typical us e *
Sterilization (male or
female)
Intrauterine Devices
(IUDs)
Less than 1
Hormonal Methods:
Implant
Less than 1
Injection 3
Pill
Patch 8
Vaginal Ring
Female Condom 21
Withdrawal
Natural Family Planning
(calendar, temperature, 25 - 27
cervical mucus)
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
1. Nonoxynol 9 contained within the sponge is released gradually over a 24-hour period.
2. Soft polyurethane foam sponge is formulated to feel like normal vaginal tissue.
3. Specially designed ribbon loop is attached to an interior web for maximum strength for removing
sponge.
4. Anatomically contoured indentation covers cervix to help position sponge properly.
5. Sponge exterior is carefully shaped for easy insertion.
6. Store Today® Sponge at 20-25°C (68-77°F).
B. How can I improve the effectivenes s 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 eas y is it to us e 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.
2. WARNINGS
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 trans mitted dis eas es (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 us e
within the first six weeks after giving birth
if you have ever had Toxic Shock Syndrome
during your menstrual period
if you or your sex partner has HIV/AIDS. If you do not know if you or your sex partner is infected,
choose another form of birth control
if you are allergic to sulfites. This product contains sodium metabisulfite which may cause severe
allergic reactions in some people
if you have ever had an allergic reaction to nonoxynol 9 or to this product
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.)
3. DIRECTIONS
Before using, read the back of this leaflet for diagram instructions for inserting and removing sponge.
Wash hands before use.
Remove the sponge from the pouch.
Wet the sponge thoroughly with clean water, squeeze gently several times until sponge is very
sudsy.
With the dimple side of the sponge facing up, fold sponge upward and insert the sponge deep into
the vagina as shown in diagram (see section 9). The ribbon loop must be on the bottom for easy
removal.
Protection begins right away and lasts for 24 hours even with repeated acts of intercourse.
Wait at least 6 hours after the last intercourse before removing sponge.
Do not leave s ponge in vagina for longer than 30 hours . Leaving the s ponge in vagina longer
than 30 hours may increas e the chances for vaginal irritation and s erious infections .
Do not re-us e the s ponge
If you have trouble removing the sponge from your vagina or remove only part of the sponge, call
the Mayer Labs Product Support Line at 1-877-494-2525 or contact a health professional right
away.
Do not douche while sponge is in your vagina.
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
studies have raised safety concerns that products containing the spermicide nonoxynol 9 can irritate
the vagina and rectum. Sometimes this irritation has no symptoms. This irritation may increase the
risk of getting HIV/AIDS from an infected partner
you can use nonoxynol 9 for birth control with or without a condom if you have sex with only one
partner who is not infected with HIV and who has no other sexual partners or HIV risk factors
when used correctly every time you have sex, latex condoms greatly reduce, but do not eliminate,
the risk of catching or spreading HIV, the virus that causes AIDS, and other STDs from infected
partners
use a latex condom without nonoxynol 9 if you or your sex partner has HIV/AIDS, multiple sex
partners, or other HIV risk factors
ask a health professional if you have questions about your best birth control and STD prevention
methods
store at 20-25°C (68-77°F)
A. How can I reduce the chances of a s erious infection including s exually trans mitted dis eas es
(STDs )?
Read Warnings and Other Information sections before use.
You may want to see a doctor or health professional for advice on how to reduce the risk of STDs,
especially if you have a new sex partner or multiple sex partners.
Correct use of a latex condom by your partner with every sexual act will help reduce the risk of
transmission of the human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome
(AIDS) and many sexually transmitted diseases (STDs).
Do not leave the sponge in vagina longer than 30 hours.
Make sure that all of sponge is removed from vagina.
Wash hands before inserting and removing the sponge.
C. Can I have an allergic reaction or other s ide effects from the Today® Sponge?
If you have ever had a severe allergic reaction to sulfites, do not use this product because it
contains sodium metabisulfite.
A small number of men and women may be sensitive to the spermicide, nonoxynol 9, in this product
and you should not use this product if irritation occurs and persists. Of the women in clinical trials,
between 2-3% discontinued use of the sponge because of itching, irritation, or rash, and 1-3%
discontinued because of allergic reactions.
F. How does Today® Sponge s tay in place? Can the s ponge get los t in my body?
Today® Sponge is held in place by the muscles of the upper vagina. The cup-like indention in the
sponge helps to keep it in place directly over the cervix.
The opening from the vagina to the uterus is far too small for the sponge to pass through. There is
no other normal opening in the vagina that would provide access to any other part of your body.
Today Vaginal Contraceptive Sponge is Sit on the edge of a chair with knees apart.
inserted through the vaginal opening and Place a good source of light about an arm's
placed in the deepest part of the vagina, just length in front of you and use a hand mirror to
below the cervix. The cervix is at the bottom examine the region between the outer "lips,"
end of the uterus, and has a small opening or labia. The vaginal opening is between the
through which sperm must travel to reach and labia, just below the small urinary opening and
fertilize the egg. one or two inches below the clitoris.
It is easier to find the cervix if you squat. You can bring your cervix down closer to the
Insert your finger gently into the vagina, vaginal opening, and thus make it easier to
reaching up on an angle toward the back until locate, by bearing down. Take a deep breath
you find the firm, round surface of the cervix. and bear down as if you were having a bowel
It feels something like the tip of your nose. In movement. You should now be able to locate
some cases, it may be difficult to locate, so your cervix just above the vaginal opening.
you may have to explore a bit before you find This technique is also very useful for
it. removing the sponge.
2. Wet the sponge thoroughly with clean tap water. The water activates the spermicide.
3. Squeeze the sponge gently several times until it becomes very sudsy. Be sure you do not squeeze
the sponge dry. (The sponge should remain sudsy for insertion.)
4. Fold the sides of the sponge upward with a finger along each side to support it. The sponge
should look long and narrow. Be sure the string loop dangles underneath the sponge from one end
of the fold to the other, as shown.
5. Bend your wrist and point the end of the folded sponge toward your vagina. Be sure that you can
see the fold when you look down at it and that the string loop dangles below.
6. From a standing position, squat down slightly and spread your legs apart. Use your free hand to
spread apart the lips of the vagina. You may also stand with one foot on a stool or chair, sit cross-
legged or lie down. The semi-squatting position seems to work best for most women. Slide the
sponge into the opening of the vagina as far as your fingers will go. Let the sponge slide through
your fingers, deeper into the vagina.
7. Now use one or two fingers to push the sponge gently up into your vagina as far as it will go. Be
careful not to push a fingernail through the sponge. Check the position of the sponge by sliding
your finger around the edge of the sponge to make sure your cervix is not exposed. You should
be able to feel the string loop.
A. Removal Procedure
1. Always wait 6 hours after your last act of intercourse before removing the sponge.
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.
4. Dispose of the sponge in a waste container. Do not flus h it down the toilet.
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 ris k of infection,
it is important that you get all parts of s ponge out of the vagina. If you have difficulty getting parts
of s ponge out of the vagina, call the Mayer Labs Product Support Line at 1-877-494-2525 or
contact a health profes s ional right away.
Product Information
Prod uct T yp e HUMAN O TC DRUG Ite m Cod e (S ource ) NDC:44376 -10 0
Product Characteristics
Color WHITE S core
S hap e RO UND S iz e
Flavor Imp rint Cod e
Contains
Packag ing
# Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date
1 NDC:44376 -10 0 -0 1 3 in 1 BO X 0 4/0 1/19 8 3
1 1 in 1 PO UCH; Type 0 : No t a Co mbina tio n Pro duc t
Marketing Information
Marke ting Cate gory Ap p lication Numb e r or Monograp h Citation Marke ting S tart Date Marke ting End Date
NDA NDA0 18 6 8 3 0 4/0 1/19 8 3