FDA label 83228d35-042b-375c-e053-2991aa0aeb30

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
e105ef9f-b596-410f-954d-523e392176af
SPL ID
83228d35-042b-375c-e053-2991aa0aeb30
Version
2
Effective date
2019-03-02
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 06:30:59

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 you have 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 told to do so by a dentist or doctor. When using this product fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms do not go away, advise your dentist or doctor. Stop use and ask a doctor if sore mouth symptoms do not get better 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.

Reported adverse events (FAERS/openFDA)#

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