FDA label e45422d8-9f95-519e-e053-2995a90adfb1

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: 178f6ee0-363c-46b9-8b9b-d635c4f38241
SPL ID: e45422d8-9f95-519e-e053-2995a90adfb1
Version: 2
Effective date: 2022-07-21
Source export date: 2026-11-06
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/2026-11-06/b00a73f24c6ff050408c570063640e3d80d1f71dfc9a165d1cf072a25659445a/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:59:59

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		e45422d8-9f95-519e-e053-2995a90adfb1	id
spl set id		178f6ee0-363c-46b9-8b9b-d635c4f38241	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. Avoid contact with eyes. Do not use on children under 12 years of age unless directed by a doctor. When using this product some users may experience a mild skin irritation. Stop use and ask a doctor if skin irritation becomes severe. Keep out of the reach of children. If swallowed, seek medical help or contact a Poison Control Center right away. Sun exposure should be limited by using a sunscreen agent: a sun blocking agent or protective clothing to cover bleached skin after treatment is completed to prevent darkening from reoccurring.

Reported adverse events (FAERS/openFDA)#

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