FDA.reportPublic FDA data

FDA label fc5e60f8-32a5-ebe2-e053-6294a90a95c3

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
fc5e6f2a-e816-0666-e053-6394a90a66a7
SPL ID
fc5e60f8-32a5-ebe2-e053-6294a90a95c3
Version
1
Effective date
2023-05-23
Source export date
2026-08-01
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/4d7120b2932458966cd5c2f0e3ab49319f616f09498d059c9ff283a8dac64565/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:11:39

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 external use only When using this product Avoid contact with eyes. If contact occurs, rinse thoroughly with water. 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. Stop use and ask a doctor if Rectal bleeding occurs. Condition worsens or does not improve within 7 days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.