FDA label ab1ce5cf-f5ca-05f4-e053-2995a90ae8ba

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: a0e3b500-1295-47cd-ab4e-503f51895bbb
SPL ID: ab1ce5cf-f5ca-05f4-e053-2995a90ae8ba
Version: 2
Effective date: 2020-07-23
Source export date: 2026-09-28
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:02:04

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		ab1ce5cf-f5ca-05f4-e053-2995a90ae8ba	id
spl set id		a0e3b500-1295-47cd-ab4e-503f51895bbb	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 Ask a doctor before use if you have - heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use, if you are presently taking a prescription drug for high blood pressure or depression When using this product - do not exceed the recommended daily dosage unless directed by a doctor, do not use this product with an applicator, if the applicator into the rectum causes additional pain. Consult a doctor promptly. Stop use and ask a doctor if - you experience bleeding, condition worsens or does not improve within 7 days, these may be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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