FDA label d678b49f-9345-4612-8730-463d0293270b

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: 4eb53e43-8a20-4b10-9612-ed4ec08b56ac
SPL ID: d678b49f-9345-4612-8730-463d0293270b
Version: 2
Effective date: 2020-01-08
Source export date: 2026-10-12
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:34:16

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		d678b49f-9345-4612-8730-463d0293270b	id
spl set id		4eb53e43-8a20-4b10-9612-ed4ec08b56ac	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. OTC - WHEN USING SECTION Avoid contact with eyes. If contact occurs, flush gently and thoroughly with water. OTC - STOP USE SECTION Discontinue use if rash or irritation occurs. OTC - KEEP OUT OF REACH OF CHILDREN SECTION Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Sun Alert Because this product may make your skin more sensitive to the sun, be certain you have adequate sunscreen protection while using this product and for a week after you discontinue use.

Reported adverse events (FAERS/openFDA)#

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