TheraCare Maximum Strength Pain Relief Patch

Manufacturer
Veridian Healthcare | Unexo Life Sciences, Private Limited
Effective date
2024-12-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:42:10

Label at a glance#

ProductTheraCare Maximum Strength Pain Relief Patch
Active ingredientLIDOCAINE
Label structure13 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Use

INDICATIONS & USAGE SECTION

temporary relieves minor pain

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • more than 1 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 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 or 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

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 1-800-222-1222 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and over:

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

Other information

OTHER SAFETY INFORMATION

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, phenoxyethanol, polyacrylic acid, polysorbate 80, propylene glycol, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackPacklabellabellabellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN4
1737778lidocaine 0.04 MG/MG Medicated PatchSCD4
1737778lidocaine 4 % Medicated PatchSY4

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
71101-001-06TheraCare Maximum Strength Pain Relief Patch1 in 1 POUCHPATCH14
71101-001-06TheraCare Maximum Strength Pain Relief Patch6 in 1 CARTONPATCH64
71101-001-24TheraCare Maximum Strength Pain Relief Patch1 in 1 POUCHPATCH14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71101-001THERACARE MAXIMUM STRENGTH PAIN RELIEF PATCH (LIDOCAINE) PATCH [VERIDIAN HEALTHCARE]4Current NDC, Legacy NDC, 3 package rows20241212_dfaf8a77-2276-4791-e053-2a95a90a3288.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
71101-00171101-001-06, 71101-001-24

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
TheraCare Maximum Strength Pain Relief PatchLIDOCAINEVeridian Healthcaredfaf8a77-2276-4791-e053-2a95a90a32882024-12-10WarningsExact identifier
ndc (package): 71101-001-24
ndc (package): 71101-001-06
ndc (product): 71101-001
ndc11 (package): 71101000124
ndc11 (package): 71101000106
spl id: 28f04b12-7e69-bbd6-e063-6394a90a7792
spl set id: dfaf8a77-2276-4791-e053-2a95a90a3288

Reported adverse events (FAERS/openFDA)#

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