FDA label ac3838a0-f9cc-4b07-b59c-6bb887f5c435

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: 5173e084-fb0b-437a-a387-dfe908d2191f
SPL ID: ac3838a0-f9cc-4b07-b59c-6bb887f5c435
Version: 1
Effective date: 2020-06-29
Source export date: 2026-10-22
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-22/e902d457a1761a44fd3a30c39db9aa876f06b0835423db5444f8d1a30fdfcfa1/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
Import run: 20261023T001338Z
Imported at: 2026-10-23 01:39:00

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		ac3838a0-f9cc-4b07-b59c-6bb887f5c435	id
spl set id		5173e084-fb0b-437a-a387-dfe908d2191f	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 heat or flame -------------------------------------------------------------------------------------------------------- Do not use • in children less than 2 months of age • on open skin wounds -------------------------------------------------------------------------------------------------------- When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. -------------------------------------------------------------------------------------------------------- Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Reported adverse events (FAERS/openFDA)#

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