FDA label 7ace5d51-e912-4a2b-8f40-a861ffc778b4

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
25bcfa70-64f9-18d6-51b0-83282c2f84be
SPL ID
7ace5d51-e912-4a2b-8f40-a861ffc778b4
Version
6
Effective date
2020-11-25
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 05:52:05

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 cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in 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: 1. pale, gray, or blue colored skin (cyanosis) 2. headache 3. rapid heart rate 4. shortness of breath 5. dizziness or lightheadedness 6. fatigue or lack of energy For external use only 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. Do not use 1. on deep or puncture wounds 2. on animal bites 3. on serious burns 4. for teething 5. in children under age 2 When using this product 1. avoid contact with the eyes 2. do not exceed recommended dosage Stop use and ask a doctor if 1. condition worsens 2. symptoms persist for more than 7 days 3. symptoms clear up and occur again within a few days Keep out of reach of children. If swallowed, 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.