FDA label 4c2e0097-c16a-8eee-e063-6394a90a78b9

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: a3ae5f00-01f4-4a8d-8dbf-cb1f930a8146
SPL ID: 4c2e0097-c16a-8eee-e063-6394a90a78b9
Version: 6
Effective date: 2026-03-04
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:35:32

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		4c2e0097-c16a-8eee-e063-6394a90a78b9	id
spl set id		a3ae5f00-01f4-4a8d-8dbf-cb1f930a8146	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

Warnings (For external use only) Do not use this product if Pregnant or breastfeeding, ask a health professional before use. In case of accidental overdose, get medical help or contact Poison Control Center immediately. tamper evident "Do not use this product" If seal is broken or missing. When using this product do not exceed the recommended daily dosage unless directed by doctor. Certain persons can develop allergic reactions to ingredients in this product. Do not put this product into the rectum by using ‑nger or any medical device or applicator. Stop use and ask doctor if the symptoms being treated does not subside, or if redness, Irritation, swelling pain or other symptoms develop or increase.

Reported adverse events (FAERS/openFDA)#

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