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NDC 50488-2004-01 Lidocaine 4 g/g Details

Lidocaine 4 g/g

Lidocaine is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by Alexso, Inc. The primary component is LIDOCAINE.

MedlinePlus Drug Summary

Prescription lidocaine transdermal (Dermalid, Lidoderm, Ztildo) is used to relieve the pain of post-herpetic neuralgia (PHN; burning, stabbing pains, or aches that may last for months or years after a shingles infection). Nonprescription (over-the-counter) lidocaine (Absorbine Jr, Aspercreme, Lidocare, Salonpas, others) is also available to relieve minor pain in shoulders, arms, neck and legs in adults and children 12 years of age and older. Lidocaine is in a class of medications called local anesthetics. It works by stopping nerves from sending pain signals.

Related Packages: 50488-2004-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Lidocaine Transdermal Patch

Product Information

NDC	50488-2004
Product ID	50488-2004_30906cba-8a98-465d-b1d4-ac14cfbfe5fd
Associated GPIs	90850060005920
GCN Sequence Number	023447
GCN Sequence Number Description	lidocaine ADH. PATCH 4 % TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	60050
HICL Sequence Number	010705
HICL Sequence Number Description	LIDOCAINE
Brand/Generic	Generic
Proprietary Name	Lidocaine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine
Product Type	HUMAN OTC DRUG
Dosage Form	PATCH
Route	TOPICAL
Active Ingredient Strength	4
Active Ingredient Units	g/g
Substance Name	LIDOCAINE
Labeler Name	Alexso, Inc
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 50488-2004-01 (50488200401)

Pricing Information	N/A
NDC Package Code	50488-2004-1
Billing NDC	50488200401
Package	10 PATCH in 1 CARTON (50488-2004-1) / 100 g in 1 PATCH
Marketing Start Date	2020-01-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c4e41113-7bf1-4fe9-b460-73e7b839c7a2 Details

SPL UNCLASSIFIED SECTION

LIDOCAINE – Lidocaine 4% Patch

Alexso, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Lidocaine 4% Patch

Drug Facts

Active ingredient

Lidocaine 4%

Purpose

External analgesic

Uses

Temporarily relieves pain and itching associated with:

• minor burns

• sunburn

• minor cuts

• scrapes

• insect bites

• minor skin irritations

Warnings

For external use only.

Read all warnings and directions before use.

Do not use

• More than one patch at a time

• On wounds or damaged skin

• With a heating pad

• If you are allergic to any ingredients of this product

Allergy Alert: if you are allergic to any inactive ingredient of this product, contact a doctor before use.

When using this product

• Use only as directed.

• Avoid contact with eyes, mucous membranes, or rashes

• Do not tightly wrap or bandage the treated area

Stop use and ask a physician:

• If pregnant or breast feeding

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

• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 12 years of age and older:

Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.

1.: Clean and dry the affected area.
2.: Open pouch and remove one patch.
3.: Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope.
4.: Wash hands with soap and water after handling the patches.
5.: Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
6.: Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.

Children under 12 years: Ask a physician

Other information

Store at room temperature 15°-30°C (59°-86°F)

Avoid storing product in direct sunlight and protect product from excessive moisture.

Inactive ingredients

Aqua (Deionized Water), Glycerin, Sodium Polyacrylate, Propylene Glycol, Polysorbate 80, Tartaric Acid, Dihydroxyaluminium Aminoacetate, Methylparaben, Peppermint Oil

PRINCIPAL DISPLAY PANEL

Lidocaine 4% Patch

NDC 50488-2004-1

10 Patches per Box

Alexso, Inc

INGREDIENTS AND APPEARANCE

LIDOCAINE

lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50488-2004
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TARTARIC ACID (UNII: W4888I119H)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50488-2004-1	10 in 1 CARTON	01/15/2020
1		100 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	01/15/2020

Labeler - Alexso, Inc (963338061)

Revised: 10/2022

Document Id: 30906cba-8a98-465d-b1d4-ac14cfbfe5fd

Set id: c4e41113-7bf1-4fe9-b460-73e7b839c7a2

Version: 3

Effective Time: 20221027