FDA.reportPublic FDA data

FDA label 81ee02ca-3611-5e5e-e053-2a91aa0a2e98

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
4c3a1569-0fe4-4d33-a539-1d86b70a4f24
SPL ID
81ee02ca-3611-5e5e-e053-2a91aa0a2e98
Version
2
Effective date
2019-02-15
Source export date
2026-08-01
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/2026-08-01/928e480b2a9ec5fd356ebc3e5dcca70f0f57b8a051cfbb174a4421de39bb77a2/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:24:57

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 Do not use more than directed for more than 7 days unless directed by a dentist or doctor. Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days, swelling, rash or fever develops, irritation, pain or redness persists or worsens Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.