FDA label 8619d40e-d90f-088e-e053-2a91aa0ae30a

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: 446d189f-c954-4902-a88f-89475437ff68
SPL ID: 8619d40e-d90f-088e-e053-2a91aa0ae30a
Version: 1
Effective date: 2019-04-09
Source export date: 2026-09-28
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:16:52

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		8619d40e-d90f-088e-e053-2a91aa0ae30a	id
spl set id		446d189f-c954-4902-a88f-89475437ff68	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. Avoid contact with eyes. Do not use on children under 12 years of age unless directed by a doctor. When using this product some users may experience a mild skin irritation. Stop use and ask a doctor if skin irritation becomes severe. Keep out of the reach of children. If swallowed, seek medical help or contact a Poison Control Center right away. This product is not for use in the prevention of sunburn, Sun exposure should be limited by using a sunscreen agent: a sun blocking agent or protective clothing to cover bleached skin after treatment is completed to prevent darkening from reoccurring.

Reported adverse events (FAERS/openFDA)#

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