FDA.reportPublic FDA data

Lidocaine 4% Topical Patch

Manufacturer
Blue Heron Pharmaceuticals LLC
Effective date
2026-08-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-13 01:01:26

Label at a glance#

ProductLidocaine 4% Patch
Active ingredientLIDOCAINE
Label structure14 sections

Indications and uses

For the temporary relief of pain

Dosage and administration

Adult and children 12 years of age and over: Clean and dry affected area Peel patch off plastic liner and place patch on affected area for no more than 12 hours Wash hands after applying patch Under age 12, consult a physician before use For easier removal of the patch, apply rubbing alcohol or baby oil to adhesive edge while gently peeling Children under 12 years of age: Consult a doctor

Storage and handling

Store at 68-77℉ (20-25℃) - Room Temperature Do not exceed 100 o F (38 o C)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purposes

OTC - PURPOSE SECTION

Topical analgesic

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

  • If you are allergic to Lidocaine   
  • On open wounds or on damaged, broken or irritated skin
  • Remove immediately if you sense a burning sensation after application

When using this product:

OTC - WHEN USING SECTION

  • Do not use other topical products.
  • Do not allow contact with eyes or mucous membranes
  • Keep away from excessive heat.
  • Do not apply heating pad to area of use.
  • Apply only to clean, dry, untreated skin.
  • Use only as directed. Read and follow all directions and warnings on this label.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms persist for more than 7 days

If pregnant or breast-feeding,

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a physician before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If put in mouth, get medical help or contact a poison control center right away. Dispose of used product away from children and pets.

Directions

DOSAGE & ADMINISTRATION SECTION

Adult and children 12 years of age and over:

  • Clean and dry affected area
  • Peel patch off plastic liner and place patch on affected area for no more than 12 hours
  • Wash hands after applying patch
  • Under age 12, consult a physician before use
  • For easier removal of the patch, apply rubbing alcohol or baby oil to adhesive edge while gently peeling

Children under 12 years of age: Consult a doctor

Storage

STORAGE AND HANDLING SECTION

  • Store at 68-77℉ (20-25℃) - Room Temperature
  • Do not exceed 100 oF (38 oC)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylic Adhesive, Polyethylene Fabric

Questions?

OTC - QUESTIONS SECTION

Call: 813-380-0271

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85622-52185622-521-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
ACRYLIC ACIDJ94PBK7X8SIACT

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
Lidocaine 4% PatchLIDOCAINE 4%Blue Heron Pharmaceuticals LLCf41dc11d-0be1-439f-b4c7-52ad02288dd42026-08-11WarningsExact identifier
ndc (package): 85622-521-15
ndc (product): 85622-521
ndc11 (package): 85622052115
spl id: 641b85f3-2442-4302-8a0b-36af5bb2c271
spl set id: f41dc11d-0be1-439f-b4c7-52ad02288dd4

Reported adverse events (FAERS/openFDA)#

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