FDA.reportPublic FDA data

FDA label b66e7a91-9e36-64dd-e053-2a95a90a8b83

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
0162c765-512e-494b-a235-9560c303c30c
SPL ID
b66e7a91-9e36-64dd-e053-2a95a90a8b83
Version
4
Effective date
2020-12-14
Source export date
2026-08-01
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/2026-08-01/0689a4374f1490600b5244071db3b04bd3bbc29ceda7a856edb8225323adf20a/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:00:00

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 ​External use only Allergy alert: ​certain persons can develop allergic reactions to the ingredients in this product Do Not Use this product in the rectum by using fingers or any mechanical device or applicator When Using This Product do not use more than directed. Stop use and ask a doctor if pain worsens or does not improve in 7 days redness, irritation, swelling, pain or other symptoms develop or increase if bleeding occurs Keep out of the reach of children. If accidentally swallowed get medical help or contact a Poison Control Center right away.