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NDC 71101-0011-05 TheraCare Pain Relief Lidocaine 4 g/100g Details

TheraCare Pain Relief Lidocaine 4 g/100g

TheraCare Pain Relief Lidocaine is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by Veridian Healthcare. 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: 71101-0011-05
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Lidocaine Transdermal Patch

Product Information

NDC	71101-0011
Product ID	71101-011_cea6d313-304c-42ae-e053-2a95a90a4eba
Associated GPIs
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	TheraCare Pain Relief 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/100g
Substance Name	LIDOCAINE
Labeler Name	Veridian Healthcare
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	2022-12-31

Package

Package Images

NDC 71101-0011-05 (71101001105)

Pricing Information	N/A
NDC Package Code	71101-011-05
Billing NDC	71101001105
Package	5 PATCH in 1 CARTON (71101-011-05) / 9 g in 1 PATCH
Marketing Start Date	2021-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cea6cdab-28a5-5bd0-e053-2a95a90a1295 Details

Active Ingredients

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

Purpose

Topical Anesthetic

Idications and Usage

Uses: Temporaily relieves minor pains.

Warnings

For external use only.

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.

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.

Keep out of reach of children and pets.

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

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 12 hours

■ discard patch afetr single use

Children under 12 years of age: consult a physician.

Other Safety Information

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

Inactive Ingredients

Crospovidone, dihydroxyaluminum aminoacetate, edetate disodium, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol,Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Questions

TOLL-FREE

Customer Care Help Line

866-326-1313

Mon–Fri 8:30 am–4:30 pm CST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THERACARE PAIN RELIEF LIDOCAINE

lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71101-011
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
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CROSPOVIDONE (UNII: 2S7830E561)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71101-011-05	5 in 1 CARTON	10/01/2021
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	10/01/2021

Labeler - Veridian Healthcare (830437997)

Name	Address	ID/FEI	Business Operations
Establishment
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.		546872672	manufacture(71101-011)

Revised: 10/2021

Document Id: cea6d313-304c-42ae-e053-2a95a90a4eba

Set id: cea6cdab-28a5-5bd0-e053-2a95a90a1295

Version: 1

Effective Time: 20211018