4% Lidocaine Maximum Strength Pain Relief

Manufacturer
Shenzhen Finona Information Technology Co., Ltd
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:19:18

Label at a glance#

Product4% Lidocaine Maximum Strength Pain Relief
Active ingredientLIDOCAINE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

OTC - PURPOSE SECTION

Topical Anesthetic

INDICATIONS & USAGE SECTION

Use Temporarily relieves minor paln.

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use More than one patch on your body at a time On cut, initated orswollen skin On puncture wounds For more than one week without consultinga doctor lf you are allergic to any active or inactive ingredients lf pouch isdamaged or opened.

OTC - WHEN USING SECTION

When using this product Use only as directed Read and follow alldirections and warings 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 orapply local heat (such as heating pads) to the area of use Dispose of usedpatch inmanner that always keeps product away from children and pets. Usedpatches stil contain the drug product that can produce serious adverse effects ifa child or pet chews or ingests this patch.

OTC - STOP USE SECTION

Stop use and consult a doctor if Condition worsens Redness is presentlrritation 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and pets.

DOSAGE & ADMINISTRATION SECTION


Adults and children 12 years of age and over:
Clean and dry affected area Carefully remove backing from patchstarting at a corner. Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard patch aftersingle use.Children under 12 years of age: consult a physician.

INACTIVE INGREDIENT SECTION

Aluminum Glycinate
Aluminum Hydroxide
Cellulose Gum
DMDM hydantoin
Glycerin
Polyacrylic Acid
Polysorbate 80
Propylene Glycol
Ricinus Communis Seed Oil (castor)
Silica
Sodium Polyacrylate
Tartaric Acid
Titanium Dioxide
Urea
Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label2label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN2
1737778lidocaine 0.04 MG/MG Medicated PatchSCD2
1737778lidocaine 4 % Medicated PatchSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85839-011-014% Lidocaine Maximum Strength Pain Relief15 in 1 BOXPATCH152
85839-011-014% Lidocaine Maximum Strength Pain Relief1 in 1 PATCHPATCH12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85839-01185839-011-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4% Lidocaine Maximum Strength Pain ReliefLIDOCAINEShenzhen Finona Information Technology Co., Ltd3e5a5165-a773-0501-e063-6294a90ae2f42025-12-03WarningsExact identifier
ndc (package): 85839-011-01
ndc (product): 85839-011
ndc11 (package): 85839001101
spl id: 4506fd6f-c27b-bbe6-e063-6294a90a5984
spl set id: 3e5a5165-a773-0501-e063-6294a90ae2f4

Reported adverse events (FAERS/openFDA)#

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