FDA label 8a4ab25d-8cf6-46c6-b1af-de2318c4d831
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
- 23a36261-98dc-40c9-9adf-99a43b6a9ddc
- SPL ID
- 8a4ab25d-8cf6-46c6-b1af-de2318c4d831
- Version
- 5
- Effective date
- 2018-11-19
- Source export date
- 2026-10-12
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 03:00:41
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 | 8a4ab25d-8cf6-46c6-b1af-de2318c4d831 | id | |
| spl set id | 23a36261-98dc-40c9-9adf-99a43b6a9ddc | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS For external use only. Do not use in eyes. Keep out of reach of children. Do not use in large quantities, particularly over raw surfaces or blistered areas. If swallowed, get medical help or contact Poison Control Center right away.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS During or immediately following application of TRANZAREL, there may be transient stinging or burning from open areas of skin, or transient blanching (lightening), or erythema (redness) of the skin. Allergic Reactions Allergic and anaphylactoid reactions associated with lidocaine, although rare, can occur. Such reactions are characterized by angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngospasm, pruritus, shock, and urticaria. If they occur, they should be managed by conventional means. Systemic (Dose-Related) Reactions Systemic adverse reactions of lidocaine are similar in nature to those observed with other amide local anesthetic agents, including CNS excitation and/or depression (light headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest). Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness. Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.