MedPath

Lidocaine Patch

Lidocaine Patch 24 Hours

Approved
Approval ID

0a31ba9a-8283-4bf8-b6c6-6e331465622f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 20, 2025

Manufacturers
FDA

SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS

DUNS: 081225162

Products 1

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

LIDOCAINE 4%

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73317-6866
Application NumberM015
Product Classification
M
Marketing Category
C200263
G
Generic Name
LIDOCAINE 4%
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 20, 2025
FDA Product Classification

INGREDIENTS (4)

STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (STYRENE/ISOPRENE 15/85)Inactive
Code: 1SSZ6HXE7P
Classification: IACT
HYDROGENATED C6-20 POLYOLEFIN (100 CST)Inactive
Code: 39EYQ1W9RB
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
LIDOCAINEActive
Quantity: 4 g in 100 g
Code: 98PI200987
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/20/2025

Pouch

carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/20/2025

Idications and Usage

Uses: Temporaily relieves minor pains.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/20/2025

Active Ingredients

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/20/2025

Purpose

Temporarily relieves minor pain.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/20/2025

When using this product

■ use only as directed

■ read and follow all directions and warnings on this carton

■ do not allow contact with the eyes

■ do not use at the same time as other topical analgesics

■ do not bandage tightly or apply local heat (such as heating pads) to the area of use

■ do not microwave

■ 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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/20/2025

Dosage and Administration

Directions Adults and children over 12 years:

■ clean and dry affected area

■ carefully remove backing from patch starting at corner

■ apply sticky side of patch to affected area

■ use one patch for up to 24 hours. Discard patch after single use.Children under 12 years of age: consult a physician.

WARNINGS SECTION

LOINC: 34071-1Updated: 8/20/2025

Warnings

For external use only.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/20/2025

Stop use and consult a doctor

■ condition worsens

■ redness is present

■ irritation develops

■ symptoms persist for more than 7 days or clear up and occur again within a few days

■ you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 8/20/2025

If pregnant or breastfeeding, ask a health professional before use.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/20/2025

Do not Use

■ more than one patch on your body at a time

■ on cut, irritated or swollen skin

■ on puncture wounds

■ for more than one week without consulting a doctor

■ if you are allergic to any active or inactive ingredients

■ if pouch is damaged or opened.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/20/2025

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center right away 800-222-1222

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 8/20/2025

Other Safety Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/20/2025

Inactive Ingredients

Styrene Isoprene Styrene block Copolymer, Alicyclic Saturated Hydrocarbon Resin, White Mineral Oil

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/20/2025

Questions

Questions? 1-866-760-6565, Monday - Friday 8:30 a.m - 4:30 p.m. EST

Manufactured for:
AUM Pharmaceuticals
Hauppauge, NY 11788

Made in USA

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