FDA label f366a5c6-0fe4-46bb-ba59-4413da823e6e

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
387f52e1-157a-4b9e-8f98-9001c6880786
SPL ID
f366a5c6-0fe4-46bb-ba59-4413da823e6e
Version
2
Effective date
2018-05-30
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:28:54

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 for more than 7 days unless directed by a dentist or physician if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics When using this product do not exceed recommended dosage avoid contact with eyes localized allergic reactions may occur after prolonged or repeated use Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days swelling, rash or fever develops irritation, pain or redness persists or worsens Keep out of reach of children. If more than used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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