FDA.reportPublic FDA data

Lidocaine Back / Shoulder Patch

Manufacturer
Kingsway Pharmaceuticals dba NFI, LLC | ProSolus, Inc.
Effective date
2025-01-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:50:57

Label at a glance#

ProductLidocare 03
Active ingredientLIDOCAINE
Label structure8 sections

Dosage and administration

Adults and children over 12 years of age: Apply patch to affected area every 8 to 12 hours. Children 12 years or younger: Consult a physician before use. • clean and dry affected area • cut open pouch and remove the patch • remove clear protective liner from the patch • apply to affected area no more than three (3) times per day • leave in place for up to 8 but no more than 12 hours • wash hands thoroughly after a...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Use

INDICATIONS & USAGE SECTION

For the temporary relief of pain.

Warnings

WARNINGS SECTION

For external use only.

Do not use if pouch is damaged or opened. Do not use

OTC - DO NOT USE SECTION

  • on large areas of the body or on cut, irritated skin
  • on open wounds or sensitive skin
  • for more than one week without consulting a doctor
  • do not use if you are allergic to lidocaine or any of the inactive ingredients listed below.

When using this product

OTC - WHEN USING SECTION

  • use only as directed. Read and follow all directions and warnings on this package.
  • do not allow contact with the eyes
  • do not bandage or apply local heat (such as heating pads) to the area of use
  • do not reuse patch.

Stop use and ask doctor if

OTC - STOP USE SECTION

  • condition worsens
  • rash, itching or skin irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years of age: Apply patch to affected area every 8 to 12 hours.
Children 12 years or younger: Consult a physician before use.

Instructions for Use

INSTRUCTIONS FOR USE SECTION

  • clean and dry affected area
  • cut open pouch and remove the patch
  • remove clear protective liner from the patch
  • apply to affected area no more than three (3) times per day
  • leave in place for up to 8 but no more than 12 hours
  • wash hands thoroughly after applying or removing patch
  • some individuals may not experience pain relief until several minutes or hours after applying a patch
  • do not use other local anesthetic products in addition to Lidocare.

Storage Information

STORAGE AND HANDLING SECTION

  • protect from freezing or excessive heat
  • store at 68°-77°F (20°-25°C).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Crospovidone, menthoxypropanediol, non-woven backing fabric, polyester film, non-latex rubber based adhesive, vanillyl butyl ether.
 

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
NFI CONSUMER PRODUCTS
501 Fifth Street
Bristol, TN 37620
TOLL FREE: 800-432-9334
WWW.LIDOCARE.COM

PRINCIPAL DISPLAY PANEL – 3 Patch Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FROM THE MAKERS OF BLUE-EMU®
 
Lidocare™
4% LIDOCAINE
PAIN RELIEF
PATCH
BACK/SHOULDER
 
PATENT PENDING
PRESSURE ADHESIVE
PATCH
PATCH SIZE
2.5” x 6”
 
MADE IN
THE USA
 

ULTRA-FLEXIBLE
ODOR-FREE
FOR THE TEMPORARY RELIEF OF PAIN
 
3 PATCHES
1 PATCH PER POUCH

image-01
image-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN5
1737778lidocaine 0.04 MG/MG Medicated PatchSCD5
1737778lidocaine 4 % Medicated PatchSY5

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69993-400-032025-01-06C16284748780-1d6a99b39-846b-a426-e053-dadaa90af4c2Lidocaine Back / Shoulder Patch
69993-400-032024-07-30C16284748780-1d6a99b39-846b-a426-e053-dadaa90af4c2Lidocaine Back / Shoulder Patch
69993-400-032024-01-30C16284748780-1d6a99b39-846b-a426-e053-dadaa90af4c2Lidocaine Back / Shoulder Patch
69993-400-032022-02-04C16284748780-1d6a99b39-846b-a426-e053-dadaa90af4c2Lidocaine Back / Shoulder Patch
69993-400-032022-01-28C16284748780-1d6a99b39-846b-a426-e053-dadaa90af4c2Lidocaine Back / Shoulder Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69993-400-03Lidocare031 in 1 POUCHPATCH15
69993-400-03Lidocare033 in 1 CARTONPATCH35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69993-400LIDOCARE 03 (4% LIDOCAINE) PATCH [KINGSWAY PHARMACEUTICALS DBA NFI, LLC]5Current NDC, Legacy NDC, 2 package rows20250108_416ebf5a-2efb-6d0b-e054-00144ff88e88.zip

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
69993-40069993-400-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
3-(L-MENTHOXY)-2-METHYLPROPANE-1,2-DIOL649M1Y2P72IACT
VANILLYL BUTYL ETHERS2ULN37C9RIACT

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
Lidocare 034% LIDOCAINEKingsway Pharmaceuticals dba NFI, LLC416ebf5a-2efb-6d0b-e054-00144ff88e882025-01-06WarningsExact identifier
ndc (package): 69993-400-03
ndc (product): 69993-400
ndc11 (package): 69993040003
spl id: a84cbbb3-4803-48c4-841a-fd926836e803
spl set id: 416ebf5a-2efb-6d0b-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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