FDA label 13ea2ef3-c836-443e-b146-8066b0b090da

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: 1f53e99f-b3c2-4b02-a534-c7346d8be09d
SPL ID: 13ea2ef3-c836-443e-b146-8066b0b090da
Version: 3
Effective date: 2022-07-20
Source export date: 2026-09-28
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/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:13:53

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		13ea2ef3-c836-443e-b146-8066b0b090da	id
spl set id		1f53e99f-b3c2-4b02-a534-c7346d8be09d	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 Flammable. Keep away from fire or flame Stop use and ask a doctor if irritation or redness develops or persists. Do not apply around eyes. Do not use in ears & mouth When using this product, avoid contact with eyes. In case of contact flush eyes with water. Keep out of reach of children. Children under 6, use only under adult supervision. Not recommended for infants.

Reported adverse events (FAERS/openFDA)#

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