FDA.reportPublic FDA data

FDA label f18aa597-e5af-3d56-e053-2a95a90a6230

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
80d8fb8c-8e76-937d-e053-2a91aa0a9665
SPL ID
f18aa597-e5af-3d56-e053-2a95a90a6230
Version
6
Effective date
2023-01-05
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:26:56

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 external use only Avoid contact with eyes Do not exceed the recommended daily dosage unless directed by a doctor Do no use for treatment of diaper rash In case of bleeding, consult a doctor promptly Consult a doctor: Before use if you have a vaginal discharge (for external feminine itching) For external itching, do not exceed the recommended daily dosage or if bleeding occurs If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days discontinue use of this product When using this product: Do not put this product into rectum by using fingers or any mechanical device or applicator

Reported adverse events (FAERS/openFDA)#

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