FDA.reportPublic FDA data

Lidocaine Pain Relieving Patch

Manufacturer
Unexo Life Sciences Private Limited
Effective date
2022-02-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:48:11

Label at a glance#

ProductLidocaine Pain Relieving
Active ingredientLidocaine
Label structure11 sections

Indications and uses

Temporarily relieves minor pain.

Dosage and administration

Adults and children over 12 years: Clean and dry affected area. Remove film from patch (see illustration). Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard patch after single use Children 12 years of age or younger: Consult a physician.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4.0%

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain.

Warnings

WARNINGS SECTION

For external use only

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.

When using this product

OTC - WHEN USING SECTION

  • Use only as directed
  • Read and follow all directions and warnings on this pack
  • 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 ask a doctor if

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 breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children over 12 years: Clean and dry affected area. Remove film from patch (see illustration). Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard patch after single use
  • Children 12 years of age or younger: Consult a physician.

Other Information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-888-287-1915

SPL UNCLASSIFIED SECTION

Manufactured By:

UNEXO LIFE SCIENCES PVT. LTD.
B-16. Sector 4, Bawana Industrial Area,
Delhi – 110039 (INDIA)

PRINCIPAL DISPLAY PANEL - 1 Patch Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 71391-150-01

LIDOCAINE
PAIN
RELIEVING
PATCH

LIDOCAINE 4% / Topical Anesthetic

Temporarily relieves pain
Stay-Put flexible Patch
Easy to apply & remove
No-mess, single use application
Odor-free

Lasts upto 12 hours

1 PATCH
3.93 X 5.5 IN
(10cm X 14cm)

PRINCIPAL DISPLAY PANEL - 1 Patch Pouch Label
PRINCIPAL DISPLAY PANEL - 1 Patch Pouch Label

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71391-150-012025-01-30C16284748780-12cef2736-97bd-d83d-e063-dadaa90ab31fLidocaine Pain Relieving Patch
71391-150-052025-01-30C16284748780-12cef2736-97bd-d83d-e063-dadaa90ab31fLidocaine Pain Relieving Patch
71391-150-062025-01-30C16284748780-12cef2736-97bd-d83d-e063-dadaa90ab31fLidocaine Pain Relieving Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71391-150-01Lidocaine Pain Relieving1 in 1 POUCHPATCH11
71391-150-05Lidocaine Pain Relieving5 in 1 BOXPATCH51
71391-150-06Lidocaine Pain Relieving6 in 1 BOXPATCH61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71391-150LIDOCAINE PAIN RELIEVING (LIDOCAINE) PATCH [UNEXO LIFE SCIENCES PRIVATE LIMITED]1Legacy NDC, 3 package rows20220211_9b916733-4b34-427c-81e6-a62c70fa51a4.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71391-15071391-150-01, 71391-150-05, 71391-150-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
Lidocaine98PI200987ACTIB
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
GlycerinPDC6A3C0OXIACT
Kaolin24H4NWX5COIACT
MethylparabenA2I8C7HI9TIACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
Polysorbate 806OZP39ZG8HIACT
Propylene Glycol6DC9Q167V3IACT
PropylparabenZ8IX2SC1OHIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
Tartaric AcidW4888I119HIACT
Titanium Dioxide15FIX9V2JPIACT
Water059QF0KO0RIACT

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
36d74034-e99c-4c44-8d42-10035e261bed9b916733-4b34-427c-81e6-a62c70fa51a42026-07-27WarningsExact identifier
spl set id: 9b916733-4b34-427c-81e6-a62c70fa51a4