FDA label d658b63c-d2bc-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
34a99087-3423-4e85-93e5-89d2f504528b
SPL ID
d658b63c-d2bc-1438-e053-2a95a90a9f87
Version
2
Effective date
2022-01-24
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:53:46

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.