FDA.reportPublic FDA data

Lidocaine Patch 4%

Manufacturer
Global America Group LLC
Effective date
2026-08-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-03 03:04:40

Label at a glance#

ProductLidocaine Patch 4%
Active ingredientLIDOCAINE
Label structure9 sections

Dosage and administration

Adult and children 12 years of age and over : clean and dry affected area apply 1 patch at a time to affected area,not more than 3 to 4 times daily remove patch from the skin after at most 8-hour application Children under 12 years of age : consult a doctor

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. Questions or comments? Call 646-457-4800 (M-F 8AM - 5PM ET) Manufactured for: Global America Group Brooklyn, NY 11201 Made in China

Label contents#

Full prescribing information#

​

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

INDICATIONS & USAGE SECTION

Uses For temporary relief of pain

WARNINGS SECTION

Warnings (​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

  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Adult and children 12 years of age and over:

  • clean and dry affected area
  • apply 1 patch at a time to affected area,not more than 3 to 4 times daily
  • remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, edetate disodium, tartaric acid. povidone K90. polysorbate80, propylene glycol, carboxymethylcellulose sodium, kaolin, carbomer, sodium polyacrylate,purified water. phenoxyethanol.

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.

Questions or comments?
Call 646-457-4800 (M-F 8AM - 5PM ET)

Manufactured for:
Global America Group
Brooklyn, NY 11201

Made in China

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 87843-211-30

MAXIMUM STRENGTH

LIDOCAINE
PATCH 4%
TOPICAL ANESTHETIC

PAIN RELIEVING HYDROGEL TECHNOLOGY

UP TO 8 HOURS OF RELIEF

TARGETED NUMBING RELIEF

DESENSITIZES
AGGRAVATED NERVES

LOGN LASTING
COMFORT

NON-GREASY
& ODOR FREE

30 PATCHES

8 x 12cm Each

FLEXIBLE

COMFORTABLE FIT

EASY TO APPLY
EASY TO REMOVE

GLOBAL AMERICA
GROUP

LidocaineLidocaine

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87843-21187843-211-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
KAOLIN24H4NWX5COIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
TARTARIC ACIDW4888I119HIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
METHYLPARABENA2I8C7HI9TIACT

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 Patch 4%LIDOCAINE 4%Global America Group LLC1eec782d-0e56-43d2-b842-da0ae47c5dc92026-08-26WarningsExact identifier
ndc (package): 87843-211-30
ndc (product): 87843-211
ndc11 (package): 87843021130
spl id: 14e5eae6-bd6f-47b5-b8a3-10c2193f30c3
spl set id: 1eec782d-0e56-43d2-b842-da0ae47c5dc9

Reported adverse events (FAERS/openFDA)#

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