FDA label a4e276e5-348a-4605-b829-ab0d5c20d564

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: 58547770-2151-4ee0-843c-b28f97b5b665
SPL ID: a4e276e5-348a-4605-b829-ab0d5c20d564
Version: 2
Effective date: 2015-11-11
Source export date: 2026-11-06
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/f699a9578a0c5d6f5abd59491e85ce3c2c5e4567a51003fee350566c56ba5812/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run: 20261106T075659Z
Imported at: 2026-11-06 08:26:26

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		a4e276e5-348a-4605-b829-ab0d5c20d564	id
spl set id		58547770-2151-4ee0-843c-b28f97b5b665	set_id

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 • do not put in rectum • do not exceed recommended dosage unless directed by a doctor Stop use and ask a doctor if: • allergic reaction occurs • condition worsens or does not improve within 7 days • symptoms clear up and return within a few days • rectal bleeding occurs • redness, irritation, swelling, pain or other symptoms develop or increase

Reported adverse events (FAERS/openFDA)#

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