FDA label 558daa86-df6f-e639-e063-6394a90a7cd9

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
54b46411-0ff8-4b08-bf37-802b94acf5c1
SPL ID
558daa86-df6f-e639-e063-6394a90a7cd9
Version
4
Effective date
2026-07-01
Source export date
2026-09-28
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:48:47

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. Do not use if you have never had bacterial vaginosis infection diagnosed by a doctor. Ointment may damage condoms and diaphragms, potentially leading to their Ineffectiveness. When using this product: If considering its use in conjunction with other medications, it is advisable to seek guidance from a healthcare professional. Avoid the use of tampons, douches, spermicides, or other vaginal products. This is to prevent potential damage to condoms and diaphragms, which could result in a failure to provide adequate protection against pregnancy or sexually transmitted infections (STIs). Refrain from engaging in vaginal intercourse Be aware that there may be a slight uptick in vaginal burning, itching, or irritation If relief is not attained, it is recommended to consult a doctor. Stop use and ask a doctor if symptoms do not get better in 3 days symptoms persist for more than 7 days You experience a rash or hives, abdominal pain, fever, chills, nausea, or vomiting. If pregnant or breast-feeding ask a healthcare professional before use. Keep out of the reach of children If swallowed, get medical help or contact Poison Control Center right away

Reported adverse events (FAERS/openFDA)#

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