FDA.reportPublic FDA data

FDA label 83711e91-eec1-04e8-e053-2a91aa0a0adb

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
fcf27296-52ae-43b1-b1eb-d77cd6ab87f5
SPL ID
83711e91-eec1-04e8-e053-2a91aa0a0adb
Version
2
Effective date
2019-03-06
Source export date
2026-08-01
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/054d07cb7b0dcd436e53c5bdecbb921b48860de8ff372c4a586941aa9821a276/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:21:20

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

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 use more than directed • do not use for more than 7 days unless told to do so by a dentist or doctor. 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. In case of overdose, get medical help or contact a Poison Control Center right away.