Home FDA labels ea6fac20-4c6b-42bb-8efd-c43458564fe7 FDA label ea6fac20-4c6b-42bb-8efd-c43458564fe7 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 ea6fac20-4c6b-42bb-8efd-c43458564fe7
SPL ID ea6fac20-4c6b-42bb-8efd-c43458564fe7
Version 1
Effective date 2011-09-13
Source export date 2026-10-30
Source partition 2
Source file https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-30/57469fe40e5b1c0d9604dc7dbc22532ea48e8e53acfb911fc676578d98492f7e/drug-label-0002-of-0014.json.zip
Source manifest SHA-256 b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run 20261102T182004Z
Imported at 2026-11-02 18:32:02 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.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 1 matching rows.
adverse reactions ADVERSE REACTIONS The following local adverse reactions may occur with corticosteroid-containing dental pastes: burning, itching, irritation, dryness, blistering or peeling not present prior to therapy, perioral dermatitis, allergic contact dermatitis, maceration of the oral mucosa, secondary infection, and atrophy of the oral mucosa. Also, see PRECAUTIONS for potential effects of systemic absorption.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.