FDA label 419cfbd9-6cad-03c1-e063-6294a90a2784

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
ab6ef479-2567-0cf2-e053-2a95a90a272a
SPL ID
419cfbd9-6cad-03c1-e063-6294a90a2784
Version
3
Effective date
2025-10-20
Source export date
2026-11-06
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/10387d7618367cd955339e75d48af3d11f99f789153db05c529d9fad6eccc645/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:17:53

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics. Do not use for more than 7 days unless directed by a dentist or doctor. if sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly. When using this product avoid contact with eyes. If contact occures, flush with water. Stop use and consult a health care practitioner if the following symptoms appear: weakness, confusion, headache, difficulty breathing, and/or pale, grey or blue colored skin, as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use. Do not exceed recommended dosage. If more than used for pain is accidentally swaloowed, get medical help or contact a posion control center immediately. If pregnant or breast feeding, ask a health care proffesional before use. Keep out of reach of children.

warnings and cautions

Warnings Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics. Do not use for more than 7 days unless directed by a dentist or doctor. if sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly. When using this product avoid contact with eyes. If contact occures, flush with water. Stop use and consult a health care practitioner if the following symptoms appear: weakness, confusion, headache, difficulty breathing, and/or pale, grey or blue colored skin, as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use. Do not exceed recommended dosage. If more than used for pain is accidentally swaloowed, get medical help or contact a posion control center immediately. If pregnant or breast feeding, ask a health care proffesional before use. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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