FDA label 7976856f-f0e4-4f0a-849b-92cff4fb78a7

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: 57795f37-6f65-47bd-88fe-5382eb0c160a
SPL ID: 7976856f-f0e4-4f0a-849b-92cff4fb78a7
Version: 2
Effective date: 2010-12-11
Source export date: 2026-10-12
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:49:03

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		7976856f-f0e4-4f0a-849b-92cff4fb78a7	id
spl set id		57795f37-6f65-47bd-88fe-5382eb0c160a	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

5 WARNINGS AND PRECAUTIONS KEEP OUT OF REACH OF CHILDREN. 5.1 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. 5.2 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

6 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.