Lidocaine 4% Maximum OTC Strength

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)

Brand name
Lidocaine 4% Maximum OTC Strength
Generic name
LIDOCAINE
Manufacturer
Cardinal Health 107, LLC
Product type
HUMAN OTC DRUG
SPL set ID
975031df-d46d-4098-b1c0-1c0c92b41995
SPL ID
78ab2a01-a25d-48fa-9c45-5ade11bb9385
Version
2
Effective date
2025-10-20
Source export date
2026-11-06
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/2026-11-06/245ea1c0d730b312e4410f082201cbe2cb4d1936fa2918316b6ea631293cbeba/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 08:09:52
Harmonized routes table
Harmonized routes
TOPICAL

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 For external use only. Do not use ■ More than one patch on your body at a time ■ On cut, irritated or swollen skin ■ On puncture wounds ■ For more than one week without consulting a doctor ■ If you are allergic to any active or inactive ingredients ■ If pouch is damaged or opened. When using this product ■ Use only as directed ■ Read and follow all directions and warnings on this carton ■ Do not allow contact with the eyes ■ Do not use at the same time as other topical analgesics ■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use ■ Do not microwave ■ Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch. Stop use and consult a doctor ■ Condition worsens ■ Redness is present ■ Irritation develops ■ Symptoms persist for more than 7 days or clear up and occur again within a few days ■ You experience signs of skin injury, such as pain, swelling or blistering where the product was applied. If pregnant or breastfeeding ask a health professional before use Keep out of reach of children and pets If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.

Reported adverse events (FAERS/openFDA)#

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