Home FDA labels 9968aa66-9eee-1b39-e053-2995a90a1ecc FDA label 9968aa66-9eee-1b39-e053-2995a90a1ecc 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 410957b0-98bd-4dab-b660-ba0d4803cef6
SPL ID 9968aa66-9eee-1b39-e053-2995a90a1ecc
Version 3
Effective date 2019-12-11
Source export date 2026-10-12
Source partition 9
Source file https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 02:20:43 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 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.