FDA label d19b8c40-5202-4ce5-835c-3aa9f3f6dcdb

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: 9e66a5de-6fe9-41bd-933d-51f26cd30ef6
SPL ID: d19b8c40-5202-4ce5-835c-3aa9f3f6dcdb
Version: 4
Effective date: 2020-01-03
Source export date: 2026-10-12
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:35:20

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		d19b8c40-5202-4ce5-835c-3aa9f3f6dcdb	id
spl set id		9e66a5de-6fe9-41bd-933d-51f26cd30ef6	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. Avoid contact with eyes. When using this product • do not exceed the recommended daily dosage unless directed by a doctor • do not put directly in rectum by using fingers or any mechanical device 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.

Reported adverse events (FAERS/openFDA)#

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