FDA label 5e25b9c0-b5af-40c3-80ce-8d6c041d09bf

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: 5b768637-0aba-4fcf-8d38-35273312d011
SPL ID: 5e25b9c0-b5af-40c3-80ce-8d6c041d09bf
Version: 11
Effective date: 2010-12-29
Source export date: 2026-10-12
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:33:41

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		5e25b9c0-b5af-40c3-80ce-8d6c041d09bf	id
spl set id		5b768637-0aba-4fcf-8d38-35273312d011	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 and cautions

Warnings & Precautions: KEEP OUT OF REACH OF CHILDREN. General: For external use only. Avoid contact with eyes, lips or mucous membranes. If swallowed, seek medical attention or contact a Poison Control Center immediately. Information for the Patient: Use this medication only as directed by a physician. It should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

Adverse Reactions: Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication. To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA -1088 or www.fda.gov/medwatch.

Reported adverse events (FAERS/openFDA)#

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