FDA label 51dccfdb-a9c9-1d4f-e054-00144ff8d46c

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
51dccfdb-a9c8-1d4f-e054-00144ff8d46c
SPL ID
51dccfdb-a9c9-1d4f-e054-00144ff8d46c
Version
1
Effective date
2017-06-13
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:22:00

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

Warning: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water. Stop use and consult a health-care practitioner if the following symptoms appear: weakness, confusion, headache, dificulty breathing and/or pale, gray or blue coloured skin as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use. Use smallest amount possible to achieve desired result. Do not use if allergic to benzocaine or any other ingredients in the product. Use with caution in children. Do not use if tamper-evident foil seal is broken. Do not store in direct sunlight. Do not swallow.

Reported adverse events (FAERS/openFDA)#

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