FDA label d2cb9eaf-519e-43e7-b24f-7033e6ab7d2e

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
6b4e54d7-6ba8-4400-bd52-75d112e6fe50
SPL ID
d2cb9eaf-519e-43e7-b24f-7033e6ab7d2e
Version
3
Effective date
2018-01-19
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:51:06

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For vaginal use only Not for rectal (anal) use 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 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 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 Ask a doctor before use if you have recently had a miscarriage or an abortion been told that you should not become pregnant a vaginal or uterine condition, such as a vaginal septum or uterine prolapse, which may keep the product from working a new partner, multiple sex partners, or unprotected sex. Frequent use (more than once a day) of this product can increase vaginal irritation, which may increase the risk of getting the HIV/AIDS virus or other STDs from infected partners When using this product you may get vaginal irritation (burning, itching, or a rash) Stop use and ask a doctor if you or your partner get burning, itching, a rash, or other irritation of the vagina or penis you or your partner have difficult or painful urination you get abdominal pain, fever, chills, or foul-smelling vaginal discharge you become pregnant Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.