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NDC 71101-0915-06 HealthWise Lidocaine Pain relief 4 g/100g Details

HealthWise Lidocaine Pain relief 4 g/100g

HealthWise Lidocaine Pain relief is a PERCUTANEOUS; TOPICAL; TRANSDERMAL 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: 71101-0915-06
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Lidocaine Transdermal Patch

Product Information

NDC	71101-0915
Product ID	71101-915_ce2897bb-4a4b-1a20-e053-2995a90ae3ac
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	HealthWise Lidocaine Pain relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine
Product Type	HUMAN OTC DRUG
Dosage Form	PATCH
Route	PERCUTANEOUS; TOPICAL; TRANSDERMAL
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 71101-0915-06 (71101091506)

Pricing Information	N/A
NDC Package Code	71101-915-06
Billing NDC	71101091506
Package	6 POUCH in 1 BOX (71101-915-06) / 1 g in 1 POUCH
Marketing Start Date	2021-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ce28a1d0-49f1-ed6f-e053-2a95a90a50db Details

Active ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Uses

For temporary relief minor pain

Warnings

For external use only

Do not use

more than one patch on your body at a time
on cut 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 a used patch in a manner that always keeps the 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 ingest this patch.

Stop use and ask a doctor if

conditions worsen
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 an injury, such as pain, swelling, or blistering where the product was applied.

If pregnant or breast-feeding,

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.

Directions

Adults and children 12 years of age and over:

clean and dry affected area
carefully remove the backing from the patch starting at a corner
Apply the sticky side of patch to the affected area.
Use one patch for up to 12 hours
Discard patch after single use

Children under 12 years of age: consult a physician.

Other 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 or comments?

Toll free 866-326-1313

Principal Display Panel

INGREDIENTS AND APPEARANCE

HEALTHWISE LIDOCAINE PAIN RELIEF

lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71101-915
Route of Administration	TOPICAL, PERCUTANEOUS, TRANSDERMAL

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
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
KAOLIN (UNII: 24H4NWX5CO)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71101-915-06	6 in 1 BOX	10/01/2021
1		1 g in 1 POUCH; 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	10/01/2016

Labeler - Veridian Healthcare (830437997)

Name	Address	ID/FEI	Business Operations
Establishment
Foshan Aqua Gel Biotech Co., Ltd.,		529128763	manufacture(71101-915)

Revised: 10/2021

Document Id: ce2897bb-4a4b-1a20-e053-2995a90ae3ac

Set id: ce28a1d0-49f1-ed6f-e053-2a95a90a50db

Version: 1

Effective Time: 20211012