FDA label b1baafb1-ad97-14f8-e053-2995a90a6341

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
995fffc0-3203-0810-e053-2995a90ae276
SPL ID
b1baafb1-ad97-14f8-e053-2995a90a6341
Version
2
Effective date
2020-10-15
Source export date
2026-09-28
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/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:19:31

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 use only When using this product avoid contact with eyes, do not exceed recommended 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 rectal 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, symptoms clear up and return within a few days. If pregnant or breast-feeding , ask a health professional before use. 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.