Lidocaine 4% Patch

Manufacturer
Oncora Pharma, LLC
Effective date
2025-06-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-07-17 21:35:08

Label at a glance#

ProductLidocaine 4% Patch
Active ingredientLIDOCAINE
Label structure13 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 or over: 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 the removal of the protective envelope Wash hands with soap and water after handling th...

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

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

OTC - DO NOT USE SECTION

Do not use:

  • 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

OTC - WHEN USING SECTION

When using this product:

  • Use only as directed
  • Avoid contact with the eyes, mucous membranes, or rashes
  • Do not bandage tightly

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age or over:

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 the removal of 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 of age: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
  • Protect product from excessive moisture

Other Ingredients

INACTIVE INGREDIENT SECTION

Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label
label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85477-302-10EA - Each85477-3022cd184c6-2ac1-47cc-be27-75d4594683d012025-07-08

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85477-30285477-302-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-06-27full-release2026-06-01 01:05:54

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
Lidocaine 4% PatchLIDOCAINE 4%Oncora Pharma, LLC3763b75d-0919-cfe9-e063-6394a90a9c6f2025-06-27WarningsExact identifier
ndc (package): 85477-302-10
ndc (product): 85477-302
ndc11 (package): 85477030210
spl id: 6e668885-8008-4e66-ad15-6ce725c2979c
spl set id: 3763b75d-0919-cfe9-e063-6394a90a9c6f

Reported adverse events (FAERS/openFDA)#

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