FDA.reportPublic FDA data

FDA label d21c275e-697d-e95e-e053-2a95a90ad633

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
402e7786-c53a-4e8d-ba6a-5e56ce74d63e
SPL ID
d21c275e-697d-e95e-e053-2a95a90ad633
Version
4
Effective date
2021-12-01
Source export date
2026-08-01
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/29baabee7fa6726d72190670d84f1571113181a958a8119cbe97e8f0d1d955b2/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:13:53

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 Flammable: keep away from fire or flame Stop use and ask a physician if sore mouth symptoms do not improve in 7 days condition worsens or symptoms clear up and occur again within a few days swelling, rash or fever develops irritation, pain or redness persists or worsens apply only to affected area do not exceed recommended dosage avoid contact with the eyes do not use for more than 7 days unless directed by a physician or dentist Keep out of reach of children . If swallowed, get medical help or contact a poison control center immediately.