ICY HOT- lidocaine, menthol patch 
Lead Chemical Co. Ltd.

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Icy Hot Max Pain Relief Patch

Active ingredients

Lidocaine 4%
Menthol 1%

Purposes

Topical anesthetic
Topical analgesic

Use

for the temporary relief of pain

Warnings

For external use only

Do not use

on puncture wounds, cuts, irritated, damaged or swollen skin
more than 1 patch on your body at a time or with other topical analgesics at the same time
with a heating pad or apply local heat to the area of use

When using this product

use only as directed
do not bandage tightly
avoid contact with the eyes and mucous membranes
rare cases of serious burns have been reported with products of this type
a transient burning sensation may occur upon application but generally disappears in several days
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 or symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
severe burning sensation, redness, or irritation develops
you experience signs of skin 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 right away.

Directions

adults and children 12 years of age and older:

clean and dry affected area
remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
use 1 patch at a time and not more than 3 to 4 times daily

children under 12 years of age: consult a doctor

Inactive ingredients

aluminum glycinate, aluminum hydroxide, cellulose gum, glycerin, methyl acrylate/2-ethylhexyl acrylate copolymer, methylparaben, nonoxynol-30, polyacrylic acid, polysorbate 80, propylene glycol, silica, sodium polyacrylate, tartaric acid, titanium dioxide, urea, water

Package/Label Principal Display Panel

LIDOCAINE 4% + MENTHOL 1%

ICY HOT®
MAX
Pain Relief Patch

LIDOCAINE
PATCH

Maximum Strength Lidocaine
Without a Prescription*
Penetrates for Fast, Targeted Relief
Comfortable Fabric
Stays in Place

*Among OTC Topical Analgesics
Contains 1 Patch
3-15/16” x 5-1/2” (10 cm x 14 cm)

CHATTEM®
A SANOFI COMPANY
Dist. by Chattem, Inc., a Sanofi Company
P.O. Box 2219
Chattanooga, TN 37409-0219 USA
©2020
www.icyhot.com     Made in Japan.

image-01

Label

ICY HOT 
lidocaine, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-1720
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE240 mg
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM60 mg
Inactive Ingredients
Ingredient NameStrength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
NONOXYNOL-30 (UNII: JJX07DG188)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
UREA (UNII: 8W8T17847W)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62168-1720-2400 in 1 CARTON05/10/2021
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)01/15/2017
Labeler - Lead Chemical Co. Ltd. (693727091)

Revised: 1/2024
Document Id: 2ce5d809-4f1b-45b9-93f5-3fcd41b9ed34
Set id: 1830c5ce-60e2-40e7-96cb-c5f7b9357ae5
Version: 6
Effective Time: 20240102
 
Lead Chemical Co. Ltd.