FDA label a43d1c49-5d68-4811-bdd6-16eaeeb46e2f

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
9bc3dbbb-b54f-42d2-a019-a1bf6294ccbe
SPL ID
a43d1c49-5d68-4811-bdd6-16eaeeb46e2f
Version
2
Effective date
2018-09-04
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:31:38

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 and cautions

5. WARNINGS AND PRECAUTIONS METHEMOGLOBINEMIA WARNING Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Stop use and seek immediate medical attention if the patient in your care develops: • pale, gray or blue colored skin (cyanosis) • headache • rapid heart rate • shortness of breath • dizziness or lightheadedness • fatigue or lack of energy ❖ Not for use in children under 2 years of age ❖ Keep out of reach of children ❖ For professional dental use only ❖ Take care not to contaminate the bottle by reintroducing a used cotton applicator into the bottle

Reported adverse events (FAERS/openFDA)#

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