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NDC 63868-0309-06 QUALITY CHOICE PAIN RELIEF PATCHES 4 g/100g Details

QUALITY CHOICE PAIN RELIEF PATCHES 4 g/100g

QUALITY CHOICE PAIN RELIEF PATCHES is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by QUALITY CHOICE (Chain Drug Marketing Association). 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: 63868-0309-06
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Lidocaine Transdermal Patch

Product Information

NDC	63868-0309
Product ID	63868-309_c961b5cd-dbd9-da07-e053-2995a90af70a
Associated GPIs	90850060005920
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	QUALITY CHOICE PAIN RELIEF PATCHES
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/100g
Substance Name	LIDOCAINE
Labeler Name	QUALITY CHOICE (Chain Drug Marketing Association)
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 63868-0309-06 (63868030906)

Pricing Information	N/A
NDC Package Code	63868-309-06
Billing NDC	63868030906
Package	5 PATCH in 1 CARTON (63868-309-06) / 9 g in 1 PATCH
Marketing Start Date	2017-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8fa68592-7586-494b-a74e-4f6f42bc73ce Details

Active Ingredients

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

Purpose

Temporarily relieves minor pain.

Dosage and Administration

Directions Adults and children over 12 years:

■ clean and dry affected area

■ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle

■ carefully remove smaller portion of backing from patch starting at corner

■ apply sticky side of patch to affected area

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

Warnings

For external use only.

Idications and Usage

Uses: Temporaily relieves minor pains.

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.

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.

SPL UNCLASSIFIED SECTION

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

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.

Keep out of reach of children and pets.

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

Other Safety Information

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

Inactive Ingredients

Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol,

Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Questions

Customer Care Help Line

248-449-9300

www.qualitychoice.com

Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48375

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

QUALITY CHOICE PAIN RELIEF PATCHES

lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-309
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALUMINUM (UNII: CPD4NFA903)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYACRYLIC ACID (300000 MW) (UNII: A8371R0U5J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-309-06	5 in 1 CARTON	07/01/2017
1		9 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	07/01/2017

Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Name	Address	ID/FEI	Business Operations
Establishment
Foshan Aqua Gel Biotech Co.,Ltd.		529128763	manufacture(63868-309)

Revised: 8/2021

Document Id: c961b5cd-dbd9-da07-e053-2995a90af70a

Set id: 8fa68592-7586-494b-a74e-4f6f42bc73ce

Version: 2

Effective Time: 20210812