ICY HOT ARM NECK LEG AND SMALL AREAS- menthol patch ICY HOT BACK AND LARGE AREAS- menthol patch ICY HOT XL BACK AND LARGE AREAS- menthol patch

Icy Hot Back and Large Areas by

Drug Labeling and Warnings

Icy Hot Back and Large Areas by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Icy Hot® - Medicated Patch

ARM, NECK & LEG & SMALL AREAS

Active Ingredient

Menthol 5%

Purpose

Topical analgesic

Uses

• temporarily relieves minor pain associated with:
  • arthritis
    
  • simple backache
    
  • bursitis
    
  • tendonitis
    
  • muscle strains
    
  • sprains
    
  • bruises
    
  • cramps

Warnings

For external use only

When using this product

• use only as directed
  
• do not bandage tightly or use with a heating pad
  
• avoid contact with eyes and mucous membranes
  
• do not apply to wounds or damaged skin, broken or irritated skin 

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

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 over 12 years.

• remove backing from patch by grasping both ends firmly 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 one patch to affected area
  
• wear one Icy Hot Patch up to 8 hours
  
• repeat as necessary, but no more than 4 times daily

children 12 years or younger: ask a doctor

Inactive Ingredients

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

KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION FOR USAGE OF THE PRODUCT.

Distributed by Chattem, Inc.
P.O. Box 2219
Chattanooga, TN 37409-0219 USA 
©2007 www.icyhot.com  
Made in Japan.   0049602-01

Icy Hot® - Medicated Patch

BACK & LARGE AREAS

Active Ingredient

Menthol 5%

Purpose

Topical analgesic

Uses

• temporarily relieves minor pain associated with:
  • arthritis
    
  • simple backache
    
  • bursitis
    
  • tendonitis
    
  • muscle strains
    
  • sprains
    
  • bruises
    
  • cramps

Warnings

For external use only

When using this product

• use only as directed
  
• do not bandage tightly or use with a heating pad
  
• avoid contact with eyes and mucous membranes
  
• do not apply to wounds or damaged skin 

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

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 over 12 years.

• remove backing from patch by grasping both ends firmly and gently pulling until backing separates in middle
  
• carefully remove backing from patch
  
• apply one patch to affected area
  
• wear one Icy Hot Patch up to 8 hours
  
• repeat as necessary, but no more than 4 times daily

children 12 years or younger: ask a doctor

Inactive Ingredients

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

Visit us on the web at www.icyhot.com Made in Japan

Icy Hot® - Medicated Patch

XL BACK & LARGE AREAS

Active Ingredient

Menthol 5%

Purpose

Topical analgesic

Uses

• temporarily relieves minor pain associated with:
  • arthritis
    
  • simple backache
    
  • bursitis
    
  • tendonitis
    
  • muscle strains
    
  • sprains
    
  • bruises
    
  • cramps

Warnings

For external use only

When using this product

• use only as directed
  
• do not bandage tightly or use with a heating pad
  
• avoid contact with eyes and mucous membranes
  
• do not apply to wounds or damaged skin, broken or irritated skin 

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

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 over 12 years.

• remove backing from patch by grasping both ends firmly and gently pulling until backing separates
  
• 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 one patch to affected area
  
• wear one Icy Hot Patch up to 8 hours
  
• repeat as necessary, but no more than 4 times daily

children 12 years or younger: ask a doctor

Inactive Ingredients

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

KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION FOR USAGE OF THE PRODUCT.

Made in Japan. Visit us on the web at www.icyhot.com 0044855-02

Principal Display Panel

EXTRA STRENGTH
ICY HOT®  
MEDICATED PATCH
Menthol 5%
ICY to DULL the PAIN – HOT to RELAX it away®
Lasts up to 8 Hours!
Small Patch
3-1/8” x 4-5/8” (8 cm x 12 cm) each
Pain Relieving Ointment on
a Breathable Adhesive Pad
ARM. NECK & LEG
& SMALL AREAS
Contains 5 Patches in 1 Resealable Pouch

Principal Display Panel

EXTRA STRENGTH
ICY HOT®  
MEDICATED PATCH
Menthol 5%
ICY to DULL the PAIN – HOT to RELAX it away®
Lasts up to 8 Hours!
LARGE PATCH
3-15/16” x 7-13/16” (10 cm x 20 cm) each
Pain Relieving Ointment on
a Breathable Adhesive Pad
BACK
& LARGE AREAS
Contains 5 Patches
In 1 Resealable Pouch

Principal Display Panel

EXTRA STRENGTH
ICY HOT®  
MEDICATED PATCH XL
Menthol 5%
ICY to DULL the PAIN – HOT to RELAX it away®
75 % Larger
Than Regular Back Patches
Lasts up to 8 Hours!
EXTRA LARGE PATCH
5-1/2” x 9-3/4” (14 cm x 25 cm) each
Pain Relieving Ointment on
a Breathable Adhesive Pad
XL BACK
& LARGE AREAS
Contains 3 Patches
In 1 Resealable Pouch

  

Principal Display Panel

ICY HOT®  
MEDICATED
PATCH
Menthol 5%
EXTRA STRENGTH
BACK
and Large Areas
Contains 1 Patches
3-15/7” x 7-13/16” (10 cm x 20 cm) each

Principal Display Panel

ICY HOT®  
MEDICATED
PATCH
Menthol 5%
EXTRA STRENGTH
BACK
and Large Areas
Contains 10 Patches in 2 Resalable pouches
3-15/16” x 7-13/16” (10 cm x 20 cm) each

INGREDIENTS AND APPEARANCE

ICY HOT ARM NECK LEG AND SMALL AREAS 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0084
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	205.50 mg

Inactive Ingredients
Ingredient Name	Strength
ACRYLIC ACID (UNII: J94PBK7X8S)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ETHYLHEXYL ACETATE (UNII: 2C7K8OA8SB)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYL ACRYLATE (UNII: WC487PR91H)
NONOXYNOL-30 (UNII: JJX07DG188)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
TALC (UNII: 7SEV7J4R1U)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0084-1	1 in 1 CARTON	11/01/2000
1		5 in 1 POUCH; 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	11/01/2000

ICY HOT BACK AND LARGE AREAS 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0843
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	428.50 mg

Inactive Ingredients
Ingredient Name	Strength
ACRYLIC ACID (UNII: J94PBK7X8S)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ETHYLHEXYL ACETATE (UNII: 2C7K8OA8SB)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYL ACRYLATE (UNII: WC487PR91H)
NONOXYNOL-30 (UNII: JJX07DG188)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
TALC (UNII: 7SEV7J4R1U)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0843-2	1 in 1 CARTON	03/01/2003
1		6 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 41167-0843-1	1 in 1 CARTON	03/01/2003
2		5 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 41167-0843-7	3 in 1 CARTON	03/01/2003
3		5 in 1 POUCH; 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	03/01/2003

ICY HOT XL BACK AND LARGE AREAS 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0847
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	750.00 mg

Inactive Ingredients
Ingredient Name	Strength
ACRYLIC ACID (UNII: J94PBK7X8S)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ETHYLHEXYL ACETATE (UNII: 2C7K8OA8SB)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYL ACRYLATE (UNII: WC487PR91H)
NONOXYNOL-30 (UNII: JJX07DG188)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
TALC (UNII: 7SEV7J4R1U)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0847-1	1 in 1 CARTON	12/01/2007
1		3 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 41167-0847-2	1 in 1 CARTON	03/10/2017
2		4 in 1 POUCH; 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	12/01/2007

ICY HOT BACK AND LARGE AREAS 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0073
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	428.50 mg

Inactive Ingredients
Ingredient Name	Strength
ACRYLIC ACID (UNII: J94PBK7X8S)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ETHYLHEXYL ACETATE (UNII: 2C7K8OA8SB)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYL ACRYLATE (UNII: WC487PR91H)
NONOXYNOL-30 (UNII: JJX07DG188)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
TALC (UNII: 7SEV7J4R1U)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0073-8	2 in 1 CARTON	03/01/2003
1		5 in 1 POUCH; 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	03/01/2003

ICY HOT BACK AND LARGE AREAS 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0083
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	428.50 mg

Inactive Ingredients
Ingredient Name	Strength
ACRYLIC ACID (UNII: J94PBK7X8S)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ETHYLHEXYL ACETATE (UNII: 2C7K8OA8SB)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYL ACRYLATE (UNII: WC487PR91H)
NONOXYNOL-30 (UNII: JJX07DG188)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
TALC (UNII: 7SEV7J4R1U)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0083-2	1 in 1 POUCH; Type 0: Not a Combination Product	03/01/2003

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	03/01/2003

Labeler - Chattem, Inc. (003336013)