FDA.reportPublic FDA data

FDA label 0e373e16-e57e-4e88-e063-6394a90a3ca9

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
4751df47-f0b8-4da6-8760-fa5d00977851
SPL ID
0e373e16-e57e-4e88-e063-6394a90a3ca9
Version
7
Effective date
2024-01-05
Source export date
2026-08-01
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/206e0852f7011b53c21719ec5c68ac6752381d0fcd1d348f7428adad64429e89/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:17:41

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 WHEN USING THIS PRODUCT: Do not exceed the recommended daily dosage unless directed by a doctor. Do not put this product into the rectum by using fingers or any mechanical device or applicator. Do not use as a leave-on gel or for a compress. Do not use on open wounds. Stop use and ask a doctor if: • Bleeding occurs. • Condition worsens or does not improve within 7 days. If pregnant or breast-feeding, ask a health professional before use.