FDA label 3cd369fa-0ac9-4530-8f13-139df9d500ea

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: 404b3760-80db-4278-800d-dd7df48e746c
SPL ID: 3cd369fa-0ac9-4530-8f13-139df9d500ea
Version: 2
Effective date: 2022-03-28
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:49:46

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		3cd369fa-0ac9-4530-8f13-139df9d500ea	id
spl set id		404b3760-80db-4278-800d-dd7df48e746c	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 When using this product avoid unnecessary sun exposure and use a sunscreen. some users of this product may experience a mild skin irritation. do not use on children under 12 years of age, unless directed by a doctor. Stop use and ask a doctor skin irritation becomes severe or gradual darkening of the skin occurs. if pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away. Discontinue use if no improvement is seen after 3 months of treatment. Avoid unnecessary sun exposure and use a sunscreen during the day of SPF 15 or higher.

Reported adverse events (FAERS/openFDA)#

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