FDA.reportPublic FDA data

FDA label 615a4857-a67b-2852-e053-2a91aa0a53ca

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
242619de-ebb9-3e4d-e054-00144ff88e88
SPL ID
615a4857-a67b-2852-e053-2a91aa0a53ca
Version
2
Effective date
2017-12-27
Source export date
2026-09-28
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/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:58:42

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 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 Flammable : keep away from fire or flame. Avoid smoking during application and until this product has dried. Do not use more than directed for more than 7 days unless told to do so by a dentist or doctor Stop use and ask a 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 or allergic reaction, get medical help or contact a Poison Control Center right away.

warnings

Flammable : keep away from fire or flame. Avoid smoking during application and until this product has dried.

Reported adverse events (FAERS/openFDA)#

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