FDA.reportPublic FDA data

PUREGEN LABS Pain Relief 4% Lidocaine Patch

Manufacturer
Advanced Rx LLC
Effective date
2024-06-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:30

Label at a glance#

ProductPUREGEN LABS Pain Relief 4 Lidocaine
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

For the temporary relief of pain.

Dosage and administration

Adults andchildren 12 years of age and older: Clean and dry the affected area Apply a patch at a time to the affected area; not more than 3 or 4 times daily to the affected area Remove the patch from the skin after at most 8 hours of application Children under 12 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4.00 %

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses:

INDICATIONS & USAGE SECTION

  • For the temporary relief of pain.

Warnings:

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • If you are allergic to any ingredients of this product

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • localized skin reactions occur, such as rash, itching, redness, irritation
  • condition worsens, or if
  • symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Adults andchildren 12 years of age and older:
  • Clean and dry the affected area
  • Apply a patch at a time to the affected area; not more than 3 or 4 times daily to the affected area
  • Remove the patch from the skin after at most 8 hours of application
  • Children under 12 years of age: consult a doctor.

Other information:

SPL UNCLASSIFIED SECTION

  • Store at 20-25°C (68-77°F) and protect from moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Dihydroxyaluminum Aminoacetate, Disodium EDTA, Glycerin, Methylparaben, Polyvinyl Alcohol, Propylene Glycol, Propylparaben, Sodium Carboxymethyl Cellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-800-630-8895

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80513-814-30PUREGEN LABS Pain Relief 4 Lidocaine30 in 1 BOXPATCH301
80513-814-30PUREGEN LABS Pain Relief 4 Lidocaine12 g in 1 PATCHPATCH121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80513-814PUREGEN LABS PAIN RELIEF 4 LIDOCAINE (LIDOCAINE) PATCH [ADVANCED RX LLC]1Current NDC, 2 package rows20240612_9dff40d8-8d7e-4629-bea5-987f5e68477d.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80513-81480513-814-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
LIDOCAINE98PI200987ACTIB

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
PUREGEN LABS Pain Relief 4 LidocaineLIDOCAINEAdvanced Rx LLC9dff40d8-8d7e-4629-bea5-987f5e68477d2024-06-11WarningsExact identifier
ndc (package): 80513-814-30
ndc (product): 80513-814
ndc11 (package): 80513081430
spl id: 1a99684d-b57c-8eac-e063-6294a90aae2e
spl set id: 9dff40d8-8d7e-4629-bea5-987f5e68477d

Reported adverse events (FAERS/openFDA)#

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