FDA.reportPublic FDA data

FDA label 2ca898e7-199b-487d-802d-b662ab2a2db2

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
0c834b76-f367-4550-9b4e-82ade5df7094
SPL ID
2ca898e7-199b-487d-802d-b662ab2a2db2
Version
1
Effective date
2020-10-14
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:13:45

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 For external use only. Do not use • If allergic to iodine • In the eyes • On children less than 3 years old • For more than 7 days unless directed by a dentist or doctor Stop use and promptly ask your dentist or doctor if sore mouth symptoms do not improve within 7 days, if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops. Keep out of reach of children. If large amounts 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.