ICY HOT MEDICATED- menthol patch 
ICY HOT MEDICATED, BACK- menthol patch 
ICY HOT MEDICATED, XL- menthol patch 
ICY HOT MEDICATED, ADVANCED RELIEF- menthol patch 
Lead Chemical Co., Ltd.

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Icy Hot® Medicated Patch

Active Ingredient

Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches

Menthol 5%

Icy Hot Advanced Relief Patches

Menthol 7.5%

Purpose

Topical analgesic

Uses

Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches

temporarily relieves minor pain associated with:

arthritis
simple backache
bursitis
tendonitis
muscle strains
sprains
bruises
cramps

Icy Hot Advanced Relief Patches

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

Icy Hot Advanced Relief Patches

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

When using this product

Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches

use only as directed. Read and follow all directions and warnings on this label.
avoid contact with eyes and mucous membranes
rare cases of serious burns have been reported with products of this type
do not apply to wounds or damaged, broken or irritated skin
do not bandage tightly or apply local heat (such as heating pads) to the area of use
a transient burning sensation may occur upon application but generally disappears in several days

Icy Hot Advanced Relief Patches

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

Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches

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 as pain, swelling, or blistering where the product was applied

Icy Hot Advanced Relief Patches

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

Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches

adults and children over 12 years:

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
wear one Icy Hot patch for up to 8 hours
repeat as necessary, but no more than 3 times daily

children 12 years or younger: ask a doctor

Icy Hot Advanced Relief Patches

adults and children 12 years of age and older:

clean and dry affected area
gently fold the patch in half to remove center section of film backing. Apply the exposed adhesive portion to the site of pain.
remove remaining film backing from both sides and finish applying to skin
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

Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches

aluminum hydroxide, cellulose gum, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water

Icy Hot Advanced Relief Patches

glyceryl hydrogenated rosinate, mineral oil, polyisobutene, styrene/isoprene copolymer

Principal Display Panel - Arm, Neck & Leg Pouch

MENTHOL 5%

ICY HOT®
ORIGINAL
Pain Relief Patch

ARM, NECK & LEG
PATCH

FEEL IT
WORKING
INSTANTLY

Powerful Targeted Relief
Icy to Dull, Hot to Relax
Comfortable Fabric
Stays in Place

Wear For Up To 8 Hours

Contains 5 Patches in 1 Resealable Pouch
3-1/8" x 4-5/8" (8 cm x 12 cm) each 


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

Pouch Label – Arm, Neck, & Leg

Pouch Label - Arm, Neck, & Leg

Principal Display Panel – Extra Strength Back and Large Areas

ICY HOT®

MEDICATED
PATCH

Menthol 5%

BONUS
20%
MORE! one free
patch inside

TARGETED
NO MESS RELIEF

Stops Pain at
the Source
Lasts up to 8 Hours
Comfortable Fabric
Stays in Place

Pain Relieving Ointment
on a Breathable Adhesive Pad

EXTRA STRENGTH
BACK
and Large Areas

Contains 6 Patches in 1 Resealable Pouch
3-15/16” x 7-13/16” (10 cm x 20 cm) each


CHATTEM®
A SANOFI COMPANY
Distributed by Chattem, Inc., P.O. Box 2219
Chattanooga, TN 37409-0219 USA
©2017     www.icyhot.com

Pouch Label - Back and Large Areas – Bonus

Pouch Label - Back and Large Areas – Bonus

Principal Display Panel - XL Back

MENTHOL 5%

ICY HOT®
ORIGINAL
Pain Relief Patch

XL PATCH

FEEL IT
WORKING
INSTANTLY

Powerful Targeted Relief
Icy to Dull, Hot to Relax
Comfortable Fabric
Stays in Place

Wear For Up To 8 Hours

 Contains 3 Patches in 1 Resealable Pouch
5-1/2" x 9-3/4" (14 cm x 25 cm) each


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

Pouch Label - XL Back

Pouch Label - XL Back

Principal Display Panel - Extra Strength XL Back and Large Areas

MENTHOL 5%

ICY HOT®
ORIGINAL
Pain Relief Patch

XL PATCH

FEEL IT
WORKING
INSTANTLY

Powerful Targeted Relief
Icy to Dull, Hot to Relax
Comfortable Fabric
Stays in Place

Wear For Up To 8 Hours

Contains 4 Patches in 1 Resealable Pouch
5-1/2" x 9-3/4" (14 cm x 25 cm) each


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

image-06

Pouch Label - XL Back – Bonus

Principal Display Panel - Advanced Pain Relief Patch

MENTHOL 7.5%

ICY HOT®
ADVANCED
Pain Relief Patch

LARGE PATCH
MORE PAIN FIGHTING INGREDIENTS*

Fast Acting Powerful Relief
Comfortable Fabric
Stays in Place

Wear For Up To 8 Hours

Contains 5 Patches in 1 Resealable Pouch
3-15/16" x 5-1/2" (10 cm x 14 cm) each

*Per same size patch vs Icy Hot®
original strength patch


Dist. by: Chattem, Inc., a Sanofi Company
P.O. Box 2219
Chattanooga, TN 37409-0219 USA
©2021     www.icyhot.com

image-08

Pouch Label - Advanced Pain Relief Patch

ICY HOT  MEDICATED
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0084
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM205.5 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
NONOXYNOL-30 (UNII: JJX07DG188)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
TALC (UNII: 7SEV7J4R1U)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62168-0084-3270 in 1 BOX06/09/202106/30/2026
15 in 1 POUCH; Type 0: Not a Combination Product
2NDC:62168-0084-4160 in 1 CARTON12/08/2023
25 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)11/01/2000
ICY HOT  MEDICATED, BACK
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0843
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM428.5 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
NONOXYNOL-30 (UNII: JJX07DG188)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
TALC (UNII: 7SEV7J4R1U)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62168-0843-980 in 1 CARTON10/16/201703/31/2024
16 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)03/01/200303/31/2024
ICY HOT  MEDICATED, XL
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0847
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM750 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
NONOXYNOL-30 (UNII: JJX07DG188)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
TALC (UNII: 7SEV7J4R1U)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62168-0847-4100 in 1 BOX06/01/201103/31/2024
1NDC:62168-0847-34 in 1 POUCH; Type 0: Not a Combination Product
2NDC:62168-0847-5120 in 1 CARTON05/17/202107/31/2026
23 in 1 POUCH; Type 0: Not a Combination Product
3NDC:62168-0847-6100 in 1 BOX05/12/202101/31/2025
34 in 1 POUCH; Type 0: Not a Combination Product
4NDC:62168-0847-7100 in 1 CARTON09/19/2023
43 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)12/01/2007
ICY HOT  MEDICATED, ADVANCED RELIEF
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0805
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM210 mg
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62168-0805-4300 in 1 BOX07/05/202103/31/2024
15 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)12/01/201203/31/2024
Labeler - Lead Chemical Co., Ltd. (693727091)

Revised: 3/2024
Document Id: c70f745a-5342-4d6d-8ea0-2bc82111a35d
Set id: d4e13689-8973-4041-9f33-e710547dcdee
Version: 12
Effective Time: 20240304
 
Lead Chemical Co., Ltd.