ICY HOT PRO PAIN RELIEF- camphor, menthol patch 
Lead Chemical Co., Ltd.

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.

----------

ICY HOT® PRO Pain Relief Patch

Active ingredients

Camphor 3%
Menthol 5%

Purpose

Topical analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints associated with:

▪
arthritis
▪
simple backache
▪
strains
▪
sprains
▪
bruises

Warnings

For external use only

Do not use

▪
on wounds or on irritated or damaged skin
▪
with a heating pad

When using this product

▪
use only as directed
▪
do not bandage tightly
▪
avoid contact with eyes and mucous membranes
▪
do not expose the area to local heat or to direct sunlight
▪
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
▪
avoid applying into skin folds

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
▪
redness is present or excessive skin irritation occurs
▪
you experience severe burning 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.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and older:

▪
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
▪
apply to affected area not more than 3 to 4 times daily
▪
wash hands after applying or removing patch. Throw away the patch by folding sticky ends together.

children under 12 years of age: ask a doctor

Inactive ingredients

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

Principal Display Panel – Pouch Label

ICY HOT®
 
PRO
PAIN RELIEF
PATCH
 
WEAR FOR UP
TO 8 HOUR
 
EXTRA STRENGTH WITH 2 PAIN RELIEVERS
 
MENTHOL 5%
CAMPHOR 3%
 
Contains 5 Patches in 1 Resealable Pouch
3-15/16" x 5-1/2" (10 cm x 14 cm) each
 
 
SANOFI CONSUMER HEALTH CARE
Dist. by: Chattem, Inc., a Sanofi Company
P.O. Box 2219, Chattanooga, TN 37409-0219 USA
©2022     www.icyhot.com

image-01

Label

ICY HOT  PRO PAIN RELIEF
camphor, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0210
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)180 mg
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM300 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GLYCERIN (UNII: PDC6A3C0OX)  
NONOXYNOL-30 (UNII: JJX07DG188)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
TALC (UNII: 7SEV7J4R1U)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62168-0210-1160 in 1 CARTON01/31/2023
15 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/31/2023
Labeler - Lead Chemical Co., Ltd. (693727091)

Revised: 9/2022
Document Id: 0ce4a95a-b739-45a8-a836-3fd6245f3280
Set id: 0ce4a95a-b739-45a8-a836-3fd6245f3280
Version: 1
Effective Time: 20220905
 
Lead Chemical Co., Ltd.