MedPath

4% Lidocaine Patch

84735-010 4% Lidocaine Patch

Approved
Approval ID

35a15e60-b33c-5065-e063-6294a90ad9df

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 21, 2025

Manufacturers
FDA

Hengyang Chuangjiujia Trading Co., Ltd.

DUNS: 977292157

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 Code84735-010
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 21, 2025
FDA Product Classification

INGREDIENTS (16)

ALUMINUM GLYCINATEInactive
Code: 1K713C615K
Classification: IACT
POLYACRYLIC ACID (250000 MW)Inactive
Code: 9G2MAD7J6W
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALUMINUM HYDROXIDEInactive
Code: 5QB0T2IUN0
Classification: IACT
CELLULOSE GUMInactive
Code: K679OBS311
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DMDM HYDANTOINInactive
Code: BYR0546TOW
Classification: IACT
SILICAInactive
Code: ETJ7Z6XBU4
Classification: IACT
UREAInactive
Code: 8W8T17847W
Classification: IACT
LIDOCAINEActive
Quantity: 0.04 g in 1 1
Code: 98PI200987
Classification: ACTIB
RICINUS COMMUNIS (CASTOR) SEED OILInactive
Code: D5340Y2I9G
Classification: IACT
SODIUM POLYACRYLATE (2500000 MW)Inactive
Code: 05I15JNI2J
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/21/2025

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/21/2025

Use Temperarily relicwes miner pain.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/21/2025

Lidocaine 4%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/21/2025

Topical Aneslhetic

WARNINGS SECTION

LOINC: 34071-1Updated: 5/21/2025

For external use only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/21/2025

Do not use More than one patch on your body at a time On gut, initated orswollen gkin On puncture wounds For more than one week without consultinga doctor if you are allergic to any aclive or inactive ingrediantsm lf pouch iscambged or opred.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/21/2025

When using this product Use only as directed Read and follow all directionsand warings on this carton Do not allow oontact with the oyes Do not use atthe same lime as oler bopical analgesics Do nat bandage lighlly or apoly localheat (such as heating pads, to the area of use Dispose of uged patch inmannerihat always keeps product away irom children and pots, Lised paiches siilcontain the drug product that can produce gerious adverge elfecis if a child or petchaws or ingasis ihis patchh.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/21/2025

Stop use and consult a doctor if condtion worsensm Redness is presert lniation develops Sympioms persist for more than 7 dlays or clear up and oocuragain willin a ferw darys You coperienoe signs of skin injury, such as pain, sweling or bllslering where the product was applled.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/21/2025

Keep out of reach of children and pets.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/23/2025

Adults and chldren 12 years of age and over: Clean and dry affected areaCarefully remove backing from patchstarting at a corner. Apply sticky sideof patch to affected area. Use one patch for up to 12 hours. Discard patchaftersingle use. Children under 12 years of age: consult a physician.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/21/2025

Aluminum Glycinate
Aluminum Hydroxide
Cellulose Gum (Sodium CMC)
DMDM Hydantoin
Glycerin
Polyacrylic Acid
Polysorbate 80
Propylene Glycol
Ricinus Communis (Castor) Seed Oil
Silica (Colloidal)
Sodium Polyacrylate
Tartaric Acid
Titanium Dioxide
Urea
Water (Purified Water)

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4% Lidocaine Patch - FDA Drug Approval Details