FDA label d4400095-41ff-45ed-9787-ac3efd02a5cc

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: 4629ed0e-f304-4fe7-b593-ea5b8c05503f
SPL ID: d4400095-41ff-45ed-9787-ac3efd02a5cc
Version: 2
Effective date: 2012-07-17
Source export date: 2026-09-28
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:30:45

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		d4400095-41ff-45ed-9787-ac3efd02a5cc	id
spl set id		4629ed0e-f304-4fe7-b593-ea5b8c05503f	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: For external use only. Not to be swallowed. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Discontinue use if sign of irritation or rash appears. If irritation or rash persists, consult physician. DIRECTIONS: Adults and children 6 months of age and over, apply liberally and smoothly 15 minutes before exposure to the sun. Reapply after swimming, excessive perspiring or after towel drying. Children under 6 months of age consult a physician.

Reported adverse events (FAERS/openFDA)#

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