Icy Hot Medicated

Dosage form: patch
Ingredients: MENTHOL 205.5mg
Labeler: Lead Chemical Co. Ltd.
NDC Code: 62168-0084

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® Medicated Patch

Active Ingredient

Menthol 5%

Menthol 7.5%

Purpose

Topical analgesic

Uses

temporarily relieves minor aches and pains 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, broken or irritated skin
  • do not use at the same time as other topical analgesics

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 - 5% Menthol

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 up to 8 hours
  • repeat as necessary, but no more than 3 times daily

children over 12 years or younger: ask a doctor

Directions - 7.5% Menthol

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 over 12 years or younger: ask a doctor

Inactive Ingredients - 5% Menthol

aluminum hydroxide, carmellose sodium, 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

Inactive Ingredients - 7.5% Menthol

glyceryl hydrogenated rosinate, hydrated silica, mineral oil, PEG-400, polyisobutene, styrene/isoprene copolymer

Distributed by Chattem, Inc., P.O. Box 2219

Chattanooga, TN 37409-0219 USA ©2011 www.icyhot.com

Made in Japan.                    

Principal Display Panel - Arm, Neck, & Leg Pouch

EXTRA STRENGTH

ICY HOT®  

PATCH

Menthol 5%

Pain Relieving Ointment on
a Breathable Adhesive Pad

ICY to DULL the PAIN – HOT to RELAX it away®

Contains 5 Patches in 1 Resealable Pouch

  • Icy and Hot Therapy for pain on a soft and dry medicated patch
  • Concentrates medicine at the site of pain
  • Holds medicine on painful muscles or joints for long-lasting relief 

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 

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

Pain Relieving Ointment on
a Breathable Adhesive Pad

Pouch Label - Back and Large Areas

Principal Display Panel - Back & Large Areas - Single Patch

EXTRA STRENGTH

ICY HOT®  

MEDICATED

PATCH

Menthol 5%

ICY to DULL the PAIN - HOT to RELAX it away®

  • Icy & Hot Therapy for pain
  • Concentrates medicine at the site of pain for long-lasting relief
  • 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

Contains 1 Patch

BACK
& LARGE AREAS

Pouch Label - Back and Large Areas

Principal Display Panel - XL

EXTRA STRENGTH

ICY HOT®  

MEDICATED

PATCH XL

Menthol 5%

Pain Relieving Ointment on
a Breathable Adhesive Pad

ICY TO DULL THE PAIN
HOT TO RELAX IT AWAY
®

Contains 3 Patches In 1 Resealable Pouch 

  • Icy and Hot Therapy for pain on a soft and dry medicated patch
  • Concentrates medicine at the site of pain
  • Holds medicine on painful muscles or joints for long-lasting relief

3 - 6" x 11" (14 cm x 25 cm) each

Pouch Label - XL Back

Principal Display Panel - Extra Strength Back and Large Areas

EXTRA STRENGTH

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

Principal Display Panel - Extra Strength XL Back and Large Areas

EXTRA STRENGTH

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

Principal Display Panel - Advanced Relief

ICY HOT®  

ADVANCED RELIEF

MEDICATED 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 Front

ICY HOT  MEDICATED
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0084
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL205.5 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
GLYCERIN 
ISOPROPYL MYRISTATE 
METHYL ACRYLATE 
NONOXYNOL-30 
POLYACRYLIC ACID (250000 MW) 
POLYSORBATE 80 
SODIUM POLYACRYLATE (2500000 MW) 
SORBITAN SESQUIOLEATE 
TALC 
TARTARIC ACID 
TITANIUM DIOXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:62168-0084-2270 POUCH in 1 BOX
1NDC:62168-0084-15 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/01/2000
ICY HOT  MEDICATED, BACK
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0843
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL428.5 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
GLYCERIN 
ISOPROPYL MYRISTATE 
METHYL ACRYLATE 
NONOXYNOL-30 
POLYACRYLIC ACID (250000 MW) 
POLYSORBATE 80 
SODIUM POLYACRYLATE (2500000 MW) 
SORBITAN SESQUIOLEATE 
TALC 
TARTARIC ACID 
TITANIUM DIOXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:62168-0843-4135 POUCH in 1 BOX
1NDC:62168-0843-15 PATCH in 1 POUCH
2NDC:62168-0843-5540 POUCH in 1 BOX
2NDC:62168-0843-21 PATCH in 1 POUCH
3NDC:62168-0843-6135 POUCH in 1 BOX
3NDC:62168-0843-36 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2003
ICY HOT  MEDICATED, XL
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0847
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL750 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
GLYCERIN 
ISOPROPYL MYRISTATE 
METHYL ACRYLATE 
NONOXYNOL-30 
POLYACRYLIC ACID (250000 MW) 
POLYSORBATE 80 
SODIUM POLYACRYLATE (2500000 MW) 
SORBITAN SESQUIOLEATE 
TALC 
TARTARIC ACID 
TITANIUM DIOXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:62168-0847-2120 POUCH in 1 BOX
1NDC:62168-0847-13 PATCH in 1 POUCH
2NDC:62168-0847-4100 POUCH in 1 BOX
2NDC:62168-0847-34 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/01/2007
ICY HOT  MEDICATED, ADVANCED RELIEF
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0805
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL210 mg
Inactive Ingredients
Ingredient NameStrength
HYDRATED SILICA 
MINERAL OIL 
POLYETHYLENE GLYCOL 400 
POLYISOBUTYLENE (1000 MW) 
Packaging
#Item CodePackage Description
1NDC:62168-0805-2300 POUCH in 1 BOX
1NDC:62168-0805-14 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/01/2012
Labeler - Lead Chemical Co. Ltd. (693727091)
Registrant - Lead Chemical Co. Ltd. (693727091)
Establishment
NameAddressID/FEIOperations
Lead Chemical Co. Ltd.693727091ANALYSIS(62168-0084, 62168-0843, 62168-0847), MANUFACTURE(62168-0084, 62168-0843, 62168-0847)
Establishment
NameAddressID/FEIOperations
Lead Chemical Co. Ltd.691590425ANALYSIS(62168-0805), MANUFACTURE(62168-0805)

Revised: 11/2012
 
Lead Chemical Co. Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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