FDA label 6ce16c04-c41b-42dc-e053-2a91aa0aafd9

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
0faa7c2e-e197-4ef3-b9e3-c703b239c192
SPL ID
6ce16c04-c41b-42dc-e053-2a91aa0aafd9
Version
5
Effective date
2018-05-23
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:31:08

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 Use smallest amount possible to achieve desired result. Do not eat for one hour following use. Do not chew gum or food while numbness persists. Apply to area with a cotton applicator as needed. If the following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, gray or blue coloured skin, stop use and consult a heath care practitioner. These symptoms may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use. Do not use if allergic to benzocaine or any other ingredient in the product. Use with caution in children. Hypersensitivity/allergy has been known to occure, in which case, discontinue use. Store in a tight container. Protect from light.

Reported adverse events (FAERS/openFDA)#

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