FDA label 471aefb4-6fdf-5f8c-e063-6394a90a3b47

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
bc93a1e8-aa36-6735-e053-2995a90ad6e8
SPL ID
471aefb4-6fdf-5f8c-e063-6394a90a3b47
Version
4
Effective date
2025-12-29
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:38:39

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 never had a vaginal yeast infection diagnosed by a doctor This yeast treatment may damage condoms and diaphragms and cause them to fall. Ask a doctor before use if you have vaginal itching abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, foul-smelling discharge. You may have a more serious condition. vaginal yeast infections often. been exposed to the HIV that cause AIDS are under 12 years of age When using this product do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or STDs do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur. stop use and ask a doctor if symptoms do not improve in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, foul-smelling 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 PoisonOCntrol Center right away.

Reported adverse events (FAERS/openFDA)#

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