Health Wise Pain Relief 4% Lidocaine Patch

Healthy Wise Pain Relief Lidocaine Patch by

Drug Labeling and Warnings

Healthy Wise Pain Relief Lidocaine Patch by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, Foshan Aqua Gel Biotech Co., Ltd.,.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTHY WISE PAIN RELIEF LIDOCAINE PATCH- lidocaine 4% patch 
Veridian Healthcare

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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Health Wise Pain Relief 4% Lidocaine Patch

Active Ingredient

Lidocaine 4.0%

Purpose

Topical Anesthetic

Use

Temporarily relieves minor pain.

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 anesthetics
• 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 is a child or pet chews or ingests this patch.

Stop use and consult a doctor if

• Condition 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 skin injury, such as pain, swelling, or blistering where the product was applied.

Keep out of reach of children and pets

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

If pregnant or breastfeeding

ask a health professional before use

Directions

Adults and children 12 years of age and over: Clean and dry affected area. Carefully remove backing from patch. Apply sticky side of patch to affected area. Use one patch for up to 24 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, carboxymethylcellulose sodium, glycerin, iodopropynyl butylcarbamate, kaolin,
petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium
polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol

HealthyWise Pain Relief 4% Lidocaine Patch

HEALTHY WISE PAIN RELIEF LIDOCAINE PATCH 
lidocaine 4% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-002
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
KAOLIN (UNII: 24H4NWX5CO)
TARTARIC ACID (UNII: W4888I119H)
POVIDONE (UNII: FZ989GH94E)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
PETROLATUM (UNII: 4T6H12BN9U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
WATER (UNII: 059QF0KO0R)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-002-25	25 in 1 CARTON	07/01/2023
1		1 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/01/2023

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co., Ltd.,.		529128763	manufacture(71101-002)

Revised: 8/2023

Document Id: 027df3f1-638b-8b75-e063-6394a90ae96a

34390-5

Set id: 0190196d-5f78-042b-e063-6294a90a3714

Version: 2

Effective Time: 20230809