Home FDA labels 5f0112bb-31bf-d5c1-e053-2a91aa0a44d5 FDA label 5f0112bb-31bf-d5c1-e053-2a91aa0a44d5 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 1f4d7ad3-433c-40b3-842e-73a327214d86
SPL ID 5f0112bb-31bf-d5c1-e053-2a91aa0a44d5
Version 3
Effective date 2017-11-27
Source export date 2026-09-28
Source partition 12
Source file https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 06:23:37 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.