Pain Relief Patch 4% Lidocaine

Manufacturer
Reliable 1 Laboratories LLC
Effective date
2025-01-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:52:48

Label at a glance#

ProductPain Relief Patch 4% Lidocaine
Active ingredientLIDOCAINE
Label structure13 sections

Dosage and administration

Adult and children over 12 years Clean and dry affected area. Remove backing from patch by firmly grasping both ends and gently pulling until back separates in middle. Carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area. Use 1 patch for up to 12 hours. Children 12 years or younger: ask a doctor

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

OTC - PURPOSE SECTION

Topical Anesthetic

USE

INDICATIONS & USAGE SECTION

Use Temporarily Relieves Minor Pain

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

  • More than one patch on your body at a time
  • On cut, irritated swollen skin
  • On puncture wounds
  • For more than one week without consulting a doctor
  • At the same time as other topical analgesics

When using this product

OTC - WHEN USING SECTION

  • Use only as directed.
  • Read and follow all directions and warnings on this label.
  • Rare case of serious burns have been reported with products of this type.
  • Do not apply to wounds or damaged, broken or irritated skin.
  • Do not allow contact with the eyes and mucous membranes.
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
  • Do not use at the same time as other topical analgesic.
  • 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
  • A transient burning sensation may occur upon application but generally disappears in several days.
  • If a severe burning sensation occurs, discontinue use immediately.
  • Discontinue use at least 1 hour before a bath or shower.
  • Do not use immediately after a bath or shower.

Stop Use and ask 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 and pets. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adult and children over 12 years

  • Clean and dry affected area.
  • Remove backing from patch by firmly grasping both ends and gently pulling until back separates in middle.
  • Carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area.
  • Use 1 patch for up to 12 hours.

Children 12 years or younger:

  • ask a doctor

Other information:

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENT SECTION

Alpha Tocopherol Acetate, Aluminium Glycinate, Aluminium Hydroxide, Aluminium Sulphate, Butylated Hydroxytoluene, DMDM Hydantoin, Glycerine, Kaolin, Polyacrylic Acid, Polysorbate, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitan Monooleate, Tartaric Acid & Titanium Dioxide.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69618-082-35

Pain Relief Patch

4% Lidocaine

Topical Anesthetic/ Analgesic

Temporary Pain Relief

Back & Neck

Shoulders

Knee & Elbow

*compare to active ingredient in Aspercream Patches

Fast Acting 12/HR Max Strength

6 patches: 10cm X 14CM, individually packaged

Questions? Call 516-341-0666 Mon-Fri 9am-5pm

Distributed by

Reliable 1 Laboratories LLC

99 W. Hawthorne Ave, Suite 610

Valley Stream, NY 11580

PouchPouchCartonCarton

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
69618-082-35Pain Relief Patch 4% Lidocaine6 in 1 CARTONPATCH62
69618-082-35Pain Relief Patch 4% Lidocaine1 in 1 POUCHPATCH12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-082PAIN RELIEF PATCH 4% LIDOCAINE (LIDOCAINE) PATCH [RELIABLE 1 LABORATORIES LLC]2Current NDC, 2 package rows20250117_2b624763-c310-63d9-e063-6394a90a1928.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-082-35EA - Each69618-082b9205b90-afdb-4b2f-b77e-f72e856a2f4612025-02-10

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69618-08269618-082-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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
Pain Relief Patch 4% LidocaineLIDOCAINEReliable 1 Laboratories LLC2b624763-c310-63d9-e063-6394a90a19282025-01-15WarningsExact identifier
ndc (package): 69618-082-35
ndc (product): 69618-082
ndc11 (package): 69618008235
spl id: 2bc89175-4b76-6936-e063-6394a90a8321
spl set id: 2b624763-c310-63d9-e063-6394a90a1928

Reported adverse events (FAERS/openFDA)#

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