FDA.reportPublic FDA data

FDA label ae04eeb3-2aeb-43de-bd32-ab303da64c7c

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
18eb9158-e9e2-4d81-84e4-d2c47285aa92
SPL ID
ae04eeb3-2aeb-43de-bd32-ab303da64c7c
Version
4
Effective date
2013-09-17
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:21:33

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

Warnings Do not use this product for more than 7 days unless directed by a dentist or doctor. When using this product: • do not swallow • avoid contact with eyes Stop use and ask a doctor if: • swelling, rash or fever develops • irritation, pain, or redness persists or worsens • sore mouth symptoms do not improve in 7 days Keep out of the reach of children. If more than used for rinsing is swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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