FDA label 0855ea57-fd18-44a0-94e6-3b7df3f7401f

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: 297441a9-7084-45cc-b6a3-2ca63ab3002d
SPL ID: 0855ea57-fd18-44a0-94e6-3b7df3f7401f
Version: 1
Effective date: 2017-12-28
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 01:33:49

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		0855ea57-fd18-44a0-94e6-3b7df3f7401f	id
spl set id		297441a9-7084-45cc-b6a3-2ca63ab3002d	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 Do not use on irritated or broken skin on children under 12 years old to prevent sunburn in combination with products containing Resorcinol, Phenol, or Salicylic Acid When using this product mild irritation or temporary skin darkening may occur avoid contact with eyes avoid unnecessary sun exposure Stop use and consult a doctor if darkening persists irritation becomes severe If pregnant or breast feeding, consult a doctor before use. KEEP OUT OF REACH OF CHILDREN. If swallowed, call poison control or get medical attention immediately.

Reported adverse events (FAERS/openFDA)#

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