Lidocaine Patch

Manufacturer
AARNA USA INC.
Effective date
2025-08-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:10:56

Label at a glance#

ProductLidocaine Patch
Active ingredientLIDOCAINE
Label structure14 sections

Dosage and administration

Directions Adults and children over 12 years: ■ clean and dry affected area ■ carefully remove backing from patch starting at corner ■ apply sticky side of patch to affected area ■ use one patch for up to 24 hours. Discard patch after single use. Children under 12 years of age: consult a physician.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Purpose

OTC - PURPOSE SECTION

Temporarily relieves minor pain.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions Adults and children over 12 years:

■ clean and dry affected area

■ carefully remove backing from patch starting at corner

■ apply sticky side of patch to affected area

■ use one patch for up to 24 hours. Discard patch after single use. Children under 12 years of age:consult a physician.

Warnings

WARNINGS SECTION

For external use only.

Idications and Usage

INDICATIONS & USAGE SECTION

Uses: Temporaily relieves minor pains.

When using this product

OTC - WHEN USING SECTION

■ 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

OTC - STOP USE SECTION

■ 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

Do not Use

OTC - DO NOT USE SECTION

■ 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.

Questions

OTC - QUESTIONS SECTION

Questions? 1-866-225-6999, Monday - Friday 8:30 a.m - 4:30 p.m. EST

Manufactured for:

AARNA USA INC.

Leland,NC 28451

Made in USA

Keep out of reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away 800-222-1222

Other Safety Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Styrene Isoprene Styrene block Copolymer, Alicyclic Saturated Hydrocarbon Resin, White Mineral Oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN1
1737778lidocaine 0.04 MG/MG Medicated PatchSCD1
1737778lidocaine 4 % Medicated PatchSY1

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
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
82568-0042-3Lidocaine Patch9 g in 1 PATCHPATCH91
82568-0042-3Lidocaine Patch15 in 1 CARTONPATCH151
82568-0042-4Lidocaine Patch30 in 1 CARTONPATCH301
82568-0042-4Lidocaine Patch9 g in 1 PATCHPATCH91

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82568-0042-3EA - Each82568-004241d3e2cf-0b26-46b9-bb65-06af9475a9be12025-11-13
82568-0042-4EA - Each82568-0042876b694a-2c4e-4b48-8d61-09c4766316c212025-11-13

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82568-004282568-0042-3, 82568-0042-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
Lidocaine PatchLIDOCAINE 4% MAXIMUM STRENGTH 24 HRAARNA USA INC.3cabd7ab-a9ae-ac06-e063-6394a90aaa8c2025-08-18WarningsExact identifier
ndc (package): 82568-0042-3
ndc (package): 82568-0042-4
ndc (product): 82568-0042
ndc11 (package): 82568004204
ndc11 (package): 82568004203
spl id: 3cabe282-23d0-0234-e063-6294a90a6497
spl set id: 3cabd7ab-a9ae-ac06-e063-6394a90aaa8c

Reported adverse events (FAERS/openFDA)#

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