FDA label 57eb46f3-c51f-336c-e053-2991aa0a91cc

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: be113577-f1d5-4d50-829a-f563b5d403d3
SPL ID: 57eb46f3-c51f-336c-e053-2991aa0a91cc
Version: 4
Effective date: 2017-08-29
Source export date: 2026-09-28
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/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:16:31

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		57eb46f3-c51f-336c-e053-2991aa0a91cc	id
spl set id		be113577-f1d5-4d50-829a-f563b5d403d3	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 Flammable, keep away from fire or flame. For external use only. Do not use if you are allergic to or have a known or suspected hypersensitivity to any ingredient in this product. on or near the eyes, mucous membranes, genital skin, or mouth. If product gets into the eyes, flush immediately with water. Avoid contact with broken skin. Stop use and ask doctor if irritation and redness develop. If condition persists for more than 72 hours consult a physician. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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