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NDC 71101-0911-01 THERA CARE PAIN THERAPY 4 g/100g Details

THERA CARE PAIN THERAPY 4 g/100g

THERA CARE PAIN THERAPY 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: 71101-0911-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Lidocaine Transdermal Patch

Product Information

NDC	71101-0911
Product ID	71101-911_ce647e79-57ee-804b-e053-2995a90afa25
Associated GPIs
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	THERA CARE PAIN THERAPY
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	2024-12-31

Package

Package Images

NDC 71101-0911-01 (71101091101)

Pricing Information	N/A
NDC Package Code	71101-911-01
Billing NDC	71101091101
Package	1 PATCH in 1 POUCH (71101-911-01) / 9 g in 1 PATCH
Marketing Start Date	2021-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e023bb5a-a4bc-4681-a1f4-48ca0d2cb102 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

■ carefully remove backing from patch starting at corner

■ apply sticky side of patch to affected area

■ use one patch for up to 8 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

TOLL-FREE

Customer Care Help Line

866-326-1313

Mon–Fri 8:30 am–4:30 pm CST

Manufactured For

Veridian Healthcare, LLC

Gurnee, IL 60031

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THERA CARE PAIN THERAPY

lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71101-911
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)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
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:71101-911-05	5 in 1 CARTON	05/01/2018
1		9 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC:71101-911-15	15 in 1 CARTON	05/01/2018
2		9 g in 1 PATCH; Type 0: Not a Combination Product
3	NDC:71101-911-01	1 in 1 POUCH	10/01/2021
3		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	05/01/2018

Labeler - Veridian Healthcare (830437997)

Name	Address	ID/FEI	Business Operations
Establishment
Foshan Aqua Gel Biotech Co.,Ltd.		529128763	manufacture(71101-911)

Revised: 10/2021

Document Id: ce647e79-57ee-804b-e053-2995a90afa25

Set id: e023bb5a-a4bc-4681-a1f4-48ca0d2cb102

Version: 4

Effective Time: 20211015