FDA label 0c125575-089d-4de3-948c-56cf65d0e048

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
5d80e97e-ff00-c396-e053-2a91aa0a923e
SPL ID
0c125575-089d-4de3-948c-56cf65d0e048
Version
5
Effective date
2019-11-22
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:36:50

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 Do not use unless a prior doctor’s diagnosis of anorectal condition has been made When using this product do not exceed the recommended daily dosage unless directed by a doctor Stop use and ask a doctor if • bleeding occurs • condition worsens or does not improve within 7 days • allergic reaction develops • symptoms being treated do not subside or if redness, irritation, swelling, pain, other symptoms develop or increase • Do not put this product into the rectum by using fingers or any mechanical device or applicator. • Remove petrolatum or greasy ointment before using this product because they interfere with the ability of this product to adhere properly to the skin area

Reported adverse events (FAERS/openFDA)#

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