Home FDA labels 7dfa691f-3a41-82c1-e053-2a91aa0a3be8 FDA label 7dfa691f-3a41-82c1-e053-2a91aa0a3be8 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 9ccab937-213d-45a2-8bf7-2aa9666fc1d9
SPL ID 7dfa691f-3a41-82c1-e053-2a91aa0a3be8
Version 4
Effective date 2018-12-26
Source export date 2026-11-06
Source partition 13
Source file https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-11-06/245ea1c0d730b312e4410f082201cbe2cb4d1936fa2918316b6ea631293cbeba/drug-label-0013-of-0014.json.zip
Source manifest SHA-256 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run 20261108T063105Z
Imported at 2026-11-08 08:08:03 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 1) do not use on patient with sensitive to carbamide peroxide 2) do not use on patient with oral infection 3) no to be used by pregnant or lactating women or children under 18 years old 4) to be used under the supervision of a dentist 5) do not swallow this medication
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.