FDA.reportPublic FDA data

Lidocaine Patch

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2025-09-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:14:23

Label at a glance#

ProductLidocaine
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

Temporarily relieves pain and itching associated with: • minor burns • sunburn • minor cuts • scrapes • insect bites • minor skin irritations

Dosage and administration

Adults and children 12 years of age and older: Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time. • Clean and dry the affected area. • Open pouch and remove one patch. • Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope. • Wash hands with soap and water after...

Storage and handling

Store at room temperature 15°-30°C (59°-86°F) Avoid storing product in direct sunlight and protect product from excessive moisture.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

LIDOCAINE – Lidocaine 4% Patch

Alexso, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Lidocaine 4% Patch


Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching associated with:

• minor burns

• sunburn

• minor cuts

• scrapes

• insect bites

• minor skin irritations

Warnings

WARNINGS SECTION

For external use only.

Read all warnings and directions before use.

Do not use

OTC - DO NOT USE SECTION

• More than one patch at a time

• On wounds or damaged skin

• With a heating pad

• If you are allergic to any ingredients of this product

Allergy Alert: if you are allergic to any inactive ingredient of this product, contact a doctor before use.

When using this product

OTC - WHEN USING SECTION

• Use only as directed. 

• Avoid contact with eyes, mucous membranes, or rashes

• Do not tightly wrap or bandage the treated area

Stop use and ask a physician:

OTC - STOP USE SECTION

• If pregnant or breast feeding

• If localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, and blistering

• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older:

Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.

  • Clean and dry the affected area.
  • Open pouch and remove one patch.
  • Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope.
  • Wash hands with soap and water after handling the patches.
  • Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
  • Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.

Children under 12 years: Ask a physician

Other information

STORAGE AND HANDLING SECTION

Store at room temperature 15°-30°C (59°-86°F)

Avoid storing product in direct sunlight and protect product from excessive moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Glycerin, Sodium Polyacrylate, Propylene Glycol, Polysorbate 80, Tartaric Acid, Dihydroxyaluminium Aminoacetate, Methylparaben, Peppermint Oil

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lidocaine 4% Patch

NDC 68788-4029-1

10 Patches per Box

Alexso, Inc

Relabeled By: Preferred Pharmaceuticals Inc.

Lidocaine 4% Patch
Lidocaine 4% Patch

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
68788-4029-1Lidocaine10 in 1 CARTONPATCH101
68788-4029-1Lidocaine100 g in 1 PATCHPATCH1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4029-1EA - Each68788-40292ff59a42-f5d0-47ed-9bf3-7c2cb041471512026-01-08
50488-2004-1EA - Each50488-2004c2dbb3e1-6499-46ad-b491-fe8ee052306212020-02-13

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-402968788-4029-1
50488-2004

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYSORBATE 806OZP39ZG8HIACT
TARTARIC ACIDW4888I119HIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
METHYLPARABENA2I8C7HI9TIACT
PEPPERMINT OILAV092KU4JHIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINEPreferred Pharmaceuticals Inc.2310b6ae-cacf-4b29-9b03-7f42849dfc182025-09-22WarningsExact identifier
ndc (package): 68788-4029-1
ndc (product): 68788-4029
ndc11 (package): 68788402901
spl id: 2310b6ae-cacf-4b29-9b03-7f42849dfc18
spl set id: 2310b6ae-cacf-4b29-9b03-7f42849dfc18
LidocaineLIDOCAINEAlexso, Incc4e41113-7bf1-4fe9-b460-73e7b839c7a22024-12-09WarningsExact identifier
ndc (product): 50488-2004

Reported adverse events (FAERS/openFDA)#

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