Pain Relief 4% Lidocaine Patch

Manufacturer
Unexo Life Sciences Private Limited
Effective date
2025-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:52:36

Label at a glance#

ProductPain Relief 4% Lidocaine
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%

Purpose

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, benzyl alcohol, ethylhexylglycerin, glycerin, kaolin, methylparaben, phenoxyethanol, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions or Comments

OTC - QUESTIONS SECTION

Call +91 9212228401

SPL UNCLASSIFIED SECTION

Manufactured By:

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

PRINCIPAL DISPLAY PANEL - One Patch Pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 71391-151-01

PAIN RELIEF
4% LIDOCAINE PATCH

Desensitizes aggravated nerves
and relieves pain

No-mess
Single-use application
Easy to apply and remove
Stay-put flexible gel patch
Unscented

1 PATCH
3.93 X 5.51 IN
(10cm X 14cm)

Principal Display Panel - One Patch Pouch
Principal Display Panel - One Patch Pouch

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71391-151-01Pain Relief 4% Lidocaine1 in 1 POUCHPATCH12
71391-151-05Pain Relief 4% Lidocaine5 in 1 BOXPATCH52
71391-151-06Pain Relief 4% Lidocaine6 in 1 BOXPATCH62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71391-151PAIN RELIEF 4% LIDOCAINE (LIDOCAINE) PATCH [UNEXO LIFE SCIENCES PRIVATE LIMITED]2Legacy NDC, 3 package rows20250115_bfee9be1-b265-44bd-8e82-2ec27132f82b.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71391-15171391-151-01, 71391-151-05, 71391-151-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
612ea5ff-78bd-486a-bb57-fe70ae1928ccbfee9be1-b265-44bd-8e82-2ec27132f82b2025-01-13WarningsExact identifier
spl id: 612ea5ff-78bd-486a-bb57-fe70ae1928cc
spl set id: bfee9be1-b265-44bd-8e82-2ec27132f82b

Reported adverse events (FAERS/openFDA)#

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