Home FDA labels 09f572e4-d4f9-456f-a46f-65702fdc1e5a FDA label 09f572e4-d4f9-456f-a46f-65702fdc1e5a 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 e34c724d-d08e-4533-b6cf-7185269a325f
SPL ID 09f572e4-d4f9-456f-a46f-65702fdc1e5a
Version 4
Effective date 2020-03-06
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 01:33:43 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.
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 Discontinue use if irritation appears. For topical application only. Avoid eye contact. Do not use in patients with a known history of hypersensitivity to aluminum chloride. For professional use only. Federal law restricts the product to sale or use on the order of a dentist.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.