FDA label 34480b2a-2095-4581-874c-d8fd71c4f47e

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
d033dfab-66d1-4538-abcc-f09658ef7f49
SPL ID
34480b2a-2095-4581-874c-d8fd71c4f47e
Version
2
Effective date
2010-07-08
Source export date
2026-10-12
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/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:25:30

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 Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. When using this product - avoid contact with eyes - do not exceed recommended dosage - do not use for more than 7 days unless directed by a doctor/dentist Stop use and ask a dentist or 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 then used for pain is accidentally 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.