FDA label 4c191d03-2394-44f5-ada5-029eadb8fbde

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: 5bca1291-c6c4-4976-a5b7-893de0733232
SPL ID: 4c191d03-2394-44f5-ada5-029eadb8fbde
Version: 1
Effective date: 2020-10-19
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:51:23

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		4c191d03-2394-44f5-ada5-029eadb8fbde	id
spl set id		5bca1291-c6c4-4976-a5b7-893de0733232	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

CAUTIONS AND WARNINGS For external use only. Stop use and ask a health care practitioner if irritation develops. When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water. Flammability warning: Keep away from open flame and sources of heat. If contact occurs, rinse thoroughly with water. Do not use on children/infants less than 2 years or age. Contraindications: Do not use on children/infants less than 2 years of age (unless directed by a health care practitioner). Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.

Reported adverse events (FAERS/openFDA)#

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