FDA label fc3e9b98-1785-4154-ae14-62baa8fff25f

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
a6476659-8b5f-4179-bd66-3b407f89f4ee
SPL ID
fc3e9b98-1785-4154-ae14-62baa8fff25f
Version
2
Effective date
2017-09-28
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:30:07

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings Do not use this product if patient has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics. Do not spray into or near eyes. Do not inhale. Patient: When using extension tube, do not spray in the back of the throat unless your dentist or doctor directed you to do so. When using this product: Avoid use near eyes Do not use more than recommended dosage Do not go beyond 7 days usage, unless directed by your doctor/dentist Patient: Discontinue use and consult a physician if: sore mouth symptoms do not improve in 5 days; irritation, pain, or redness persists or worsens; swelling, rash, or fever develops.

warnings and cautions

Caution: ​ ​If accidental or excessive ingestion occurs (exceeds recommended dosage) contact a physician for immediate advice or call a Poison Control Center.

Reported adverse events (FAERS/openFDA)#

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