FDA.reportPublic FDA data

Theracare 4% Lidocaine Pain Relief Patch

Manufacturer
Veridian Healthcare | InterMed Laboratories Private Limited
Effective date
2025-03-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:56:58

Label at a glance#

ProductTheraCare Pain Relief 4% Lidocaine
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

For temporary relief of pain

Dosage and administration

Adults and children 12 years of age and over: clean and dry affected area carefully remove the backing from the patch starting at a corner Apply the sticky side of patch to the affected area. Use one patch for up to 12 hours Discard patch after single use Children under 12 years of age: 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#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of 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 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 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 a used patch in a manner that always keeps the 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 ingest this patch.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • conditions worsen
  • 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 an injury, such as pain, swelling, or blistering where the product was applied.

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 a Poison Control Center 800-222-1222 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over:

  • clean and dry affected area
  • carefully remove the backing from the patch starting at a corner
  • Apply the sticky side of patch to the affected area.
  • Use one patch for up to 12 hours
  • Discard patch after single use

Children under 12 years of age: 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

dihydroxy aluminium aminoacetate, disodium EDTA, glycerin, methyl paraben, polyacrylic acid, polyvinyl alcohol, propyl paraben, propylene glycol, sodium carboxy methyl cellulose, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions or comments?

OTC - QUESTIONS SECTION

Toll free 866-326-1313

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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
71101-059-05TheraCare Pain Relief 4% Lidocaine1 g in 1 POUCHPATCH12
71101-059-05TheraCare Pain Relief 4% Lidocaine5 in 1 BOXPATCH52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71101-059THERACARE PAIN RELIEF 4% LIDOCAINE (LIDOCAINE) PATCH [VERIDIAN HEALTHCARE]2Current NDC, 2 package rows20250313_2d3fc030-5d53-2acd-e063-6294a90a11ab.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
71101-05971101-059-05

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
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
POLYVINYL ALCOHOL532B59J990IACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
TARTARIC ACIDW4888I119HIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
TheraCare Pain Relief 4% LidocaineLIDOCAINEVeridian Healthcare2d3fc030-5d53-2acd-e063-6294a90a11ab2025-03-11WarningsExact identifier
ndc (package): 71101-059-05
ndc (product): 71101-059
ndc11 (package): 71101005905
spl id: 30118985-4627-4636-e063-6294a90a8835
spl set id: 2d3fc030-5d53-2acd-e063-6294a90a11ab

Reported adverse events (FAERS/openFDA)#

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