FDA label 2020e17e-7b52-4104-827c-045bde3c7e04

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
92f1bddd-71af-427a-bce6-727adca90999
SPL ID
2020e17e-7b52-4104-827c-045bde3c7e04
Version
2
Effective date
2012-02-13
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:51:28

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 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: Π Avoid use near eyes Π Do not use more than recommended dosage Π 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.

Reported adverse events (FAERS/openFDA)#

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