FDA.reportPublic FDA data

FDA label 9a4cd875-5b39-4d4e-b17b-2ba9bb602760

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
f7a7b388-e55e-4f55-b271-0a60bb7aa694
SPL ID
9a4cd875-5b39-4d4e-b17b-2ba9bb602760
Version
3
Effective date
2018-12-11
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:23:16

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 Sexually transmitted disease (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 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 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Contents under pressure. Do not puncture or incinerate container. Do not store above 120° F.

Reported adverse events (FAERS/openFDA)#

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