FDA label ac3c7f6a-41b6-2018-e053-2a95a90ab32e

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
8effae88-ec66-fe9b-e053-2995a90aef98
SPL ID
ac3c7f6a-41b6-2018-e053-2a95a90ab32e
Version
3
Effective date
2020-08-06
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:40:54

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 Methemoglobinemia warning : Use of this product may cuse methemoglobinemia, a serious condition that must be treated promptly becasue it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: • pale, gray or blue colored skin (cyanosis) • headache • rapid heart rate • shortness or breath • dizziness or lightheadedness • fatigue or lack of engery 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.

Reported adverse events (FAERS/openFDA)#

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