FDA label ad772470-cd29-42eb-a9d9-91004fae526b

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
ef41d72c-2c0e-4382-b617-b15ddf4f30b7
SPL ID
ad772470-cd29-42eb-a9d9-91004fae526b
Version
1
Effective date
2019-11-18
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:23:07

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. Use only as directed. Do not use if you have never had a vaginal yeast infection diagnosed by a doctor. Ask a doctor before use if you have Vaginal itching and discomfort for the first time Lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. Vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. Been exposed to the human immunodeficiency virus (HIV) that causes AIDS You have an STD (sexually transmitted disease) or PID (pelvic inflammatory disease) You have frequent and painful urination When using this product If you do not get complete relief ask a doctor before using another product. Stop use and ask a doctor if Symptoms last more than 7 days You get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. If pregnant or breast-feeding, ask a health professional before use. 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.