ICY HOT MEDICATED- menthol patch ICY HOT MEDICATED, BACK- menthol patch ICY HOT MEDICATED, XL- menthol patch ICY HOT MEDICATED, ADVANCED RELIEF- menthol patch

Icy Hot by

Drug Labeling and Warnings

Icy Hot by is a Otc medication manufactured, distributed, or labeled by Lead Chemical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 pain associated with:

• arthritis
• simple backache
• muscle strains
• sprains
• bruises
• cramps

Warnings

For external use only

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.
• rare cases of serious burns have been reported with products of this type
• do not bandage tightly or apply local heat (such as heating pads) to the area of use
• avoid contact with eyes and mucous membranes
• do not apply to wounds or damaged, broken or irritated skin
• do not use at the same time as other topical analgesics

Icy Hot Advanced Relief Patches

• 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, broken or irritated skin
• do not use at the same time as other topical analgesics

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
• 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

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 over 12 years:

• 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
• use 1 patch for up to 12 hours, once a day

children 12 years or younger: 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, hydrated silica, mineral oil, PEG-400, polyisobutene, styrene/isoprene copolymer

Principal Display Panel - Arm, Neck, & Leg Pouch

ICY HOT®  

MEDICATED
PATCH
Menthol 5%

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
ARM, NECK & LEG
and Small Areas

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

Pouch Label - Arm, Neck, & Leg

Principal Display Panel - Back & Large Areas

ICY HOT®  

MEDICATED
PATCH
Menthol 5%

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

Pouch Label - Back and Large Areas

Principal Display Panel - Back & Large Areas - Single Patch

ICY HOT®  

MEDICATED
PATCH
Menthol 5%

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 1 Patch
3-15/16” x 7-13/16” (10 cm x 20 cm)

Pouch Label - Back and Large Areas - Single Patch

Principal Display Panel - XL Back

ICY HOT®  

MEDICATED
PATCH XL
Menthol 5%

75% LARGER*
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
XL BACK
and Large Areas 

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

Pouch Label - XL Back

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

Pouch Label - Back and Large Areas – Bonus

Principal Display Panel - Extra Strength XL Back and Large Areas

ICY HOT®  

MEDICATED
PATCH XL
Menthol 5%

BONUS
33%
MORE! one free
patch inside

75% LARGER*
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
XL BACK
and Large Areas

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

Pouch Label - XL Back – Bonus

Principal Display Panel – Advanced Relief

ICY HOT®  

ADVANCED RELIEF
PAIN RELIEF PATCH 
7.5 % Menthol

Advanced Relief at
the Point of Pain

- Ultra Thin, Flexible
Fabric Patch

- Long-Lasting Formula

- Easy to Apply and Remove

Pain Relieving Ointment
on Breathable, Flexible Fabric

Contains 4 Patches in 1 Resealable Pouch
3 15/16" x 5 1/2" (10 cm x 14 cm) each

Pouch Label - Advanced Relief

Principal Display Panel - Advanced Relief - Bonus

ICY HOT®  

ADVANCED RELIEF
PAIN RELIEF PATCH 
7.5 % Menthol

BONUS
25%
MORE! one free
patch inside

Advanced Relief at
the Point of Pain

- Ultra Thin, Flexible Fabric Patch

- Long-Lasting Formula

- Easy to Apply and Remove

Pain Relieving Ointment
on Breathable, Flexible Fabric

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

Pouch Label - Advanced Relief – Bonus

INGREDIENTS AND APPEARANCE

ICY HOT  MEDICATED
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62168-0084
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	205.5 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62168-0084-2	270 in 1 BOX	11/01/2000
1	NDC: 62168-0084-1	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  MEDICATED, BACK
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62168-0843
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	428.5 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62168-0843-4	135 in 1 BOX	03/01/2003	08/03/2017
1	NDC: 62168-0843-1	5 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 62168-0843-5	540 in 1 BOX	03/01/2003	02/28/2018
2	NDC: 62168-0843-2	1 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 62168-0843-6	135 in 1 BOX	06/01/2011	09/30/2017
3	NDC: 62168-0843-3	6 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 62168-0843-7	100 in 1 CARTON	09/05/2017
4		5 in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 62168-0843-8	240 in 1 CARTON	03/19/2018
5		1 in 1 POUCH; Type 0: Not a Combination Product
6	NDC: 62168-0843-9	80 in 1 CARTON	10/16/2017
6		6 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  MEDICATED, XL
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62168-0847
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	750 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62168-0847-2	120 in 1 BOX	12/01/2007
1	NDC: 62168-0847-1	3 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 62168-0847-4	100 in 1 BOX	06/01/2011
2	NDC: 62168-0847-3	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  MEDICATED, ADVANCED RELIEF
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62168-0805
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	210 mg

Inactive Ingredients
Ingredient Name	Strength
HYDRATED SILICA (UNII: Y6O7T4G8P9)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62168-0805-2	300 in 1 BOX	12/01/2012
1	NDC: 62168-0805-1	4 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 62168-0805-3	5 in 1 POUCH; Type 0: Not a Combination Product	06/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/01/2012

Labeler - Lead Chemical Co. Ltd. (693727091)

Registrant - Lead Chemical Co. Ltd. (693727091)

Establishment
Name	Address	ID/FEI	Business Operations
Lead Chemical Co. Ltd.		693727091	ANALYSIS(62168-0805, 62168-0084, 62168-0843, 62168-0847) , MANUFACTURE(62168-0084, 62168-0843, 62168-0847, 62168-0805)