FDA label f0d54306-84dc-5dbf-e053-2995a90afdb0

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: 5bc3e0a8-e793-4618-98e9-8caa67274f77
SPL ID: f0d54306-84dc-5dbf-e053-2995a90afdb0
Version: 5
Effective date: 2022-12-27
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 05:23:29

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		f0d54306-84dc-5dbf-e053-2995a90afdb0	id
spl set id		5bc3e0a8-e793-4618-98e9-8caa67274f77	set_id

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

Warning For External use only Do not use this product if: Pregnant or breast-feeding, ask a health professional before use. In case of accidental overdose, contact a doctor or Poison Control Center immediately Tamper Evident "Warranty Void.. Seal.. label atop the container is broken. When using this product: Do not exceed the recommended 6 times a day. In rare cases allergic reactions to ingredients in this product may occur. Do not put this product into the rectum by using fingers or any mechanical device or applicator. Keep out of eyes. Stop use and ask a doctor if: the symptom being treated does not subside or if redness, irritation, swrlling, pain or other symptoms develop or increases. Keep out of reach of children. In case of accidental ingestion, seek medical attention immediately.

Reported adverse events (FAERS/openFDA)#

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