FDA label 578120ea-8e99-4f6d-9737-bf5251a10288

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: 1a99fa0e-a6c2-499f-81d4-79e2d052ff74
SPL ID: 578120ea-8e99-4f6d-9737-bf5251a10288
Version: 2
Effective date: 2017-01-03
Source export date: 2026-10-12
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:48:28

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		578120ea-8e99-4f6d-9737-bf5251a10288	id
spl set id		1a99fa0e-a6c2-499f-81d4-79e2d052ff74	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

For Rectal use only For external use on intact skin only Do not use if pregnant or breast-feeding Do not exceed the recommended daily dosage unless directded by a doctor Avoid contact with eyes and mucous membranes You may experience temporary redness or stinging where the product is applied If irritation persists, consult your doctor Do not put product into the rectum by using fingers or any mechanical device or applicator

Reported adverse events (FAERS/openFDA)#

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