FDA label 45100a2a-698d-14b0-e063-6394a90a170b

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
3350d32f-5916-77e0-e063-6394a90aa76e
SPL ID
45100a2a-698d-14b0-e063-6394a90a170b
Version
2
Effective date
2025-12-03
Source export date
2026-09-28
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/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:27:27

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 an allergic reaction occurs. symptom does not improve or if redness, irritation, swelling, pain or other symptoms develop or increase. do not exceed the recommended daily dosage unless directed by a doctor. Avoid inserting this product into the rectum using fingers, medical devices, or applicators. Do not use if you are allergic to the ingredients in this product of if the seal is broken or missing. ask a health professional before use. in case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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