FDA label d658b63c-d2c8-1438-e053-2a95a90a9f87

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
d7bb46a3-585e-44a9-851b-59cde0a9fe09
SPL ID
d658b63c-d2c8-1438-e053-2a95a90a9f87
Version
2
Effective date
2022-01-24
Source export date
2026-11-06
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/2026-11-06/b0d9ca61dc485ebaf55e14a76d7d677668e40ef1e1978cdbcc4d73d58eba0b99/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:47:22

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 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 occurs, 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 swallowed, get medical help or contact a Poison Control Center immediately. ​If pregnant or breast feeding, ​ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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