FDA label e0cb37bd-6dca-de9c-e053-2a95a90a3516

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
e0cb37bd-6dc9-de9c-e053-2a95a90a3516
SPL ID
e0cb37bd-6dca-de9c-e053-2a95a90a3516
Version
1
Effective date
2022-06-06
Source export date
2026-11-06
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/2026-11-06/b00a73f24c6ff050408c570063640e3d80d1f71dfc9a165d1cf072a25659445a/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:00:32

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 external and/or intrarectal 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 -Avoid contact with eyes. -Do not exceed recommended daily dosage unless directed by a doctor. -Do not put this product into the rectum by using fingers or any mechanical device or applicator. Stop use and ask a doctor if -Bleeding occurs. -Condition worsens or does not improve within 7 days. -Allergic reaction occurs to ingredients in this product. -Symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase. If pregnant or breastfeeding , ask a doctor before use.

Reported adverse events (FAERS/openFDA)#

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