FDA.reportPublic FDA data

FDA label 3b8f41aa-a0a5-711e-e063-6294a90a56b5

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
390fb3a4-86da-d9d6-e063-6294a90abf75
SPL ID
3b8f41aa-a0a5-711e-e063-6294a90a56b5
Version
2
Effective date
2025-08-04
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:38:10

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings Warnings Do not use this product for more than 7 days unless directed by a dentist or doctor. When using this product use only as directed. Read and follow all directions and warnings on this label. Do not swallow Do not exceed recommended dosage. Stop use and ask doctor if irritation, pain or redness persists or worsens swelling, rash or fever devleops sore mouth symptoms do not improve in 7 days

warnings

When using this product use only as directed. Read and follow all directions and warnings on this label. Do not swallow Do not exceed recommended dosage.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.