FDA label 57a44bb8-1f35-4faa-afdb-4c56c5fb37f4

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: 2399ce04-c9b7-4d88-9c66-b334ecb0758f
SPL ID: 57a44bb8-1f35-4faa-afdb-4c56c5fb37f4
Version: 2
Effective date: 2011-10-21
Source export date: 2026-10-12
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:42:30

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		57a44bb8-1f35-4faa-afdb-4c56c5fb37f4	id
spl set id		2399ce04-c9b7-4d88-9c66-b334ecb0758f	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. KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER. STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION AND REDNESS DEVELOPS AND LASTS. DIRECTIONS PUMP ONTO DRY HANDS, WORK INTO A LATHER AND RINSE THOROUGHLY.

Reported adverse events (FAERS/openFDA)#

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