FDA label 37de4598-6371-2aef-e063-6294a90a3f1f

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: 36701031-d3f0-a7b8-e063-6394a90a9d38
SPL ID: 37de4598-6371-2aef-e063-6294a90a3f1f
Version: 2
Effective date: 2025-06-18
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:25:50

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		37de4598-6371-2aef-e063-6294a90a3f1f	id
spl set id		36701031-d3f0-a7b8-e063-6394a90a9d38	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 rectal use only. Not for oral consumption. Do not use if you have never had a hemorrhoid diagnosed by a doctor • If you are allergic to any of the ingredients. When using this product, do not exceed the recommended dose. Ask a doctor before use if you have heart disease • high blood pressure • thyroid disease• diabetes • difficulty urinating due to an enlarged prostate gland • bleeding hemorrhoids • a sudden change in bowel habits that persists for 2 weeks Stop use and ask a doctor. If bleeding occurs • If condition worsens or does not improve within 7 days • If redness, irritation, swelling, pain, or other symptoms develop

Reported adverse events (FAERS/openFDA)#

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