FDA label eaf10df8-48f1-c36f-e053-2a95a90abf45

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
3afd5a15-02db-27d3-e054-00144ff88e88
SPL ID
eaf10df8-48f1-c36f-e053-2a95a90abf45
Version
6
Effective date
2022-10-13
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:23:37

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 allery to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. When using this product . avoid contact with the 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 doctor if . swelling, rash or fever develops . irritation, pain or redness persists or worsens . symptoms do not improve in 7 days Keep out of reach of children. In case of overdose, 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.