FDA label 6d5d063f-bb28-dbeb-e053-2991aa0afdf3

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
daffe4b1-e8d9-4314-bd6f-e29d5d002990
SPL ID
6d5d063f-bb28-dbeb-e053-2991aa0afdf3
Version
5
Effective date
2018-05-29
Source export date
2026-09-28
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:10:27

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

Allergy Alert: do not use this product if your baby has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Reported adverse events (FAERS/openFDA)#

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