FDA.reportPublic FDA data

FDA label 0faaaa82-a06c-f9ca-e063-6294a90a150c

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
0faaaa82-a06b-f9ca-e063-6294a90a150c
SPL ID
0faaaa82-a06c-f9ca-e063-6294a90a150c
Version
1
Effective date
2024-01-23
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:27:41

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

Warnings For external use only Do not this product Pregnant or breastfeeding, ask a health professional before use. When using this product Do not exceed the recommended daily dosage unless directed by a doctor Do not put into the rectum by using fingers or any mechanical device or applicator. Stop use and ask a doctor if Condition worsens, or does not imprcve within 7 days. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treateddoes not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Discontinue use Keep out of reach of children In case of accidental ingestion, seek madical attention immediately

Reported adverse events (FAERS/openFDA)#

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