FDA.reportPublic FDA data

83559-022

Manufacturer
Henan Enokon Medical Instrument Co., Ltd.
Effective date
2026-08-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-28 00:02:05

Label at a glance#

ProductInknows Lidocaine Pain Relief Gel-Patch
Active ingredientLIDOCAINE
Label structure13 sections

Indications and uses

For temporary relief of pain

Dosage and administration

Directions Adults and children 12 years of age and over *clean and dry affected area *remove film from patch and apply to the skin (see illustration) *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 hours of application

Storage and handling

Other information *avoid storing product in direct sunlight *protect product from excessive moisture *store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

Do not use

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 have ever had an allergic reaction to this product or any of its ingredients

When Using

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

Stop Use

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

Ask Doctor

OTC - ASK DOCTOR SECTION

Ask Doctor
*If pregnant or breast-feeding, ask a health professional before use.
*Children under 12 years of age: Consult a doctor

Keep Out Of Reach Of Children

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

Directions
Adults and children 12 years of age and over
*clean and dry affected area
*remove film from patch and apply to the skin (see illustration)
*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 hours of application

Other information

STORAGE AND HANDLING SECTION

Other information
*avoid storing product in direct sunlight
*protect product from excessive moisture
*store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aluminum Glycinate,Edetate Disodium,Ethylhexylglycerin,Glycerin,Kaolin,Phenoxyethanol,Polyvinylpyrrolidone,Propylene Glycol,Sodium Carboxymethylcellulose,Sodium Polyacrylate,Tartaric Acid,Water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackPack

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeqr21.cn/DPO2j0Pack.jpg

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
83559-02283559-022-01

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
ALUMINUM GLYCINATE1K713C615KIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
KAOLIN24H4NWX5COIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM ACRYLATE7C98FKB43HIACT
TARTARIC ACIDW4888I119HIACT
WATER059QF0KO0RIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
Inknows Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.59eb9c12-9e00-0171-e063-6394a90a83422026-08-25WarningsExact identifier
ndc (package): 83559-022-01
ndc (product): 83559-022
ndc11 (package): 83559002201
spl id: 59eb9c12-9e01-0171-e063-6394a90a8342
spl set id: 59eb9c12-9e00-0171-e063-6394a90a8342

Reported adverse events (FAERS/openFDA)#

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