MedPath

Sumifun Lidocaine Pain Relief Gel-Patch

84165-016 Sumifun Lidocaine Pain Relief Gel-Patch

Approved
Approval ID

3d7dc8cc-0680-d94d-e063-6394a90ac8e8

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 29, 2025

Manufacturers
FDA

Guangzhou Zhupuyou E-commerce Co., Ltd

DUNS: 418214143

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Lidocaine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84165-016
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 29, 2025
FDA Product Classification

INGREDIENTS (15)

METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
KAOLINInactive
Code: 24H4NWX5CO
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM POLYACRYLATE (2500000 MW)Inactive
Code: 05I15JNI2J
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LIDOCAINEActive
Quantity: 0.04 g in 1 g
Code: 98PI200987
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POLYACRYLIC ACID (250000 MW)Inactive
Code: 9G2MAD7J6W
Classification: IACT
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUSInactive
Code: 1K713C615K
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/1/2025

label1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/1/2025

Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders,elbows.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/1/2025

Lidocaine 4%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/1/2025

Topical Anesthetic

WARNINGS SECTION

LOINC: 34071-1Updated: 9/1/2025

For external use only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/1/2025

more than 1 patch on your body at a time or with other topical anesthetics at the same time
on wounds or damaged skin
with a heating pad or devicemwith other ointments, creams, sprays, or liniments
if you are allergic to any ingredients of this product

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/1/2025

use only as directed
avoid contact with the eyes, mucous membraneS, orrashes
do not bandage tightly
dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/1/2025

localized skin reactions occur, such as rash, itching,redness, irritation, pain, swelling and blistering
condition worsens
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/1/2025

lf swallowed accidentally , get medical help or contact with Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/1/2025

Adults and Children above 12 years old:
Clean and dry the affected area.
Tear off the protective film and apply the exposed part of the patch to the affected area.
Carefully remove remaining film while pressing the patch firmly on the skin.
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 age of 12:Consult a doctor

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/1/2025

Dihydroxyaluminum Aminoacetate Anhydrous
Edetate Disodium
Glycerin
Kaolin
Methylparaben
Polyacrylic Acid
Polysorbate 80
PolyvinylPyrrolidone K90
Propylene Glycol
Propylparaben
Sodium Polyacrylate
Tartaric Acid
Titanium Dioxide
Water

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