FDA label 385b3cdc-56c0-4cea-982e-609a9c0049ce

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: 660a248b-fe77-4966-8c5c-c22cc0f5d240
SPL ID: 385b3cdc-56c0-4cea-982e-609a9c0049ce
Version: 1
Effective date: 2017-10-27
Source export date: 2026-11-06
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/2026-11-06/bbdc0a42bf44145a63c3752991067bece7e2a518be6cc14943d33c4987faa012/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:08:53

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		385b3cdc-56c0-4cea-982e-609a9c0049ce	id
spl set id		660a248b-fe77-4966-8c5c-c22cc0f5d240	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. If eye contact occurs flush thoroughly with water. some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor do not use on children under 12 years of age unless directed by a doctor if pregnant or nursing, seek the advice of a health professional before using When using this product do not use on cracked, irritated or inflamed skin 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.