FDA label 4b601522-3099-4501-90aa-093c4645c25a

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
97cb2db2-5623-4ebc-be03-26f1eb44c372
SPL ID
4b601522-3099-4501-90aa-093c4645c25a
Version
2
Effective date
2010-07-08
Source export date
2026-10-12
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/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:34:24

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 Allergy alert: do not use this product if your baby has a history of allergy to local anesthetics such as butacaine, benzocaine, procaine, or other "caine" anesthetics Do not use - more than directed - for more than 7 days, unless directed 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 persist, contact your dentist or doctor. Stop use and consult a dentist or doctor if: - sore mouth symptoms do not get better in 7 days - irritation, pain or redness does not go away - swelling, rash or fever develops Keep out of the reach of children. In case of overdose or allergic reaction, seek medical attention or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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