FDA label f4e94f1a-e729-4802-8407-aea7d40eb7f9

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
acb12230-7588-4960-919f-0e4caf597dac
SPL ID
f4e94f1a-e729-4802-8407-aea7d40eb7f9
Version
2
Effective date
2011-04-06
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:21:46

Warnings cross-check#

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Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings: For external use only. Flammable: Keep away from open fire or flame. When using this product avoid contact with eyes. do not use in large quantities, particularly over raw surfaces or blistered areas Stop use and ask a doctor if the condition worsens or if the symptoms clear up and occur again in a few days Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away

warnings

Warning For external use only . Flammable: Keep away from open fire or flame. Caution - Do not use in the eyes. Not for prolonged use. If the condition for which this preparation is used persists or if a rash develops, discontinue use and consult physician. Avoid contact with the eyes. Do not use over large areas of the body. Do not use for more than 7 days unless directed by a doctor. Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Inappropriate use of this product, such as application on mucous membranes, on large areas of the body or for long periods of time, or on individuals that are allergic to the amide type anesthetics, may result in serious side effects. Consultation with a doctor before using this product is strongly recommended.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

Adverse Reactions Localized Reactions During or immediately after treatment with LidoWorx™ the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation. These effects are mild and transient, resolving spontaneously within 1 or 2 hours. Other common effects is paleness (pallor or blanching) when the application time is very prolonged (over 2 hours), and less frequently alterations in temperature sensations, edema, itching and rash. Allergic Reactions Allergic and anaphylactoid reactions associated with lidocaine can occur. They are characterized by urticaria, angioedema, bronchospasm, and shock. Systemic (Dose Related) Reactions Systemic adverse reactions following appropriate use of LidoWorx™ are unlikely. Systemic adverse effects of lidocaine are similar in nature to those observed with other amide type local anesthetics 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). 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.