HEALTHWISE LIDOCAINE AND MENTHOL PAIN RELIEF- lidocaine and menthol 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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HealthWise Lidocaine + Menthol Pain Relief Patch

Active ingredients

Lidocaine 4%

Menthol 1%

Purposes

Topical anesthetic

Topical analgesic

Use

for the temporary relief minor pain

Warnings

For external use only

Do not use

■ more than 1 patch on your body at a time

■ on a 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 ask a doctor if

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 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 older:

■ clean and dry affected area

■ Carefully remove backing from patch starting at a corner

■ Apply sticky side of patch to affected area

■ use 1 patch for up to 12 hours

■ Discard patch after single use

children under 12 years of age: consult a physician

Inactive ingredients

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

PRINCIPAL DISPLAY PANEL

label

HEALTHWISE LIDOCAINE AND MENTHOL PAIN RELIEF 
lidocaine and menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-914
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
KAOLIN (UNII: 24H4NWX5CO)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71101-914-055 g in 1 CARTON; Type 0: Not a Combination Product10/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2021
Labeler - Veridian Healthcare (830437997)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Aqua Gel Biotech Co., Ltd.,529128763manufacture(71101-914)

Revised: 10/2021
Document Id: ce2ea2f0-bd68-6051-e053-2995a90a31da
Set id: ce2e9d9b-b4a4-ab61-e053-2a95a90a0642
Version: 1
Effective Time: 20211012
 
Veridian Healthcare