warnings
WARNINGS KEEP OUT OF REACH OF CHILDREN. NOT FOR OPHTHALMIC OR ORAL USE. Use of anesthetic ear drops indiscriminately may mask symptoms of infection of the middle ear.
FDA label 24374b99-d342-454b-e054-00144ff8d46c
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
- SPL set ID
- e22a729e-ea74-407c-980d-0a1c15352419
- SPL ID
- 24374b99-d342-454b-e054-00144ff8d46c
- Version
- 3
- Effective date
- 2015-11-10
- 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 05:51:18
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 24374b99-d342-454b-e054-00144ff8d46c | id | |
| spl set id | e22a729e-ea74-407c-980d-0a1c15352419 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Benzocaine can cause a hypersensitivity reaction consisting of rash, urticaria and edema. Individuals frequently exposed to ester-type local anesthetics can develop contact dermatitis characterized by erythema and pruritus. Rarely, benzocaine may induce methemoglobinemia causing respiratory distress and cyanosis which can be treated by intravenous methylene blue. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.