Icy Hot®

Drug Facts

Composition & Product

Active Ingredients

Menthol, Unspecified Form (428.5 mg)

Inactive Ingredients

Aluminum Hydroxide Carboxymethylcellulose Sodium, Unspecified Glycerin Isopropyl Myristate Nonoxynol-30 Polyacrylic Acid (250000 Mw) Polysorbate 80 Sodium Polyacrylate (2500000 Mw) Sorbitan Sesquioleate Talc Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-05-19

Medication Information

Purpose

Topical analgesic

Description

Menthol 5%

Uses

temporarily relieves minor pain associated with:

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

Warnings

For external use only

Directions

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

Active Ingredient

Menthol 5%

Inactive Ingredients

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

When Using This Product

•
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

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
•
you experience signs of skin injury, such as 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.

Principal Display Panel – Large Patch (5 Patch Pouch)

MENTHOL 5%

ICY HOT^®

ORIGINAL

Pain Relief Patch

LARGE

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

3-15/16” x 7-13/16” (10 cm x 20 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

Made in Japan

Pouch Label

Principal Display Panel – Large Patch (single Patch Pouch)

MENTHOL 5%

ICY HOT^®

ORIGINAL

Pain Relief Patch

LARGE

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 1 Patch

3-15/16” x 7-13/16” (10 cm x 20 cm)

CHATTEM_®

A SANOFI COMPANY

Dist. by Chattem, Inc., a Sanofi Company

P.O. Box 2219

Chattanooga, TN 37409-0219 USA

©2020 www.icyhot.com

Made in Japan

Pouch Label

Structured Label Content

Uses

temporarily relieves minor pain associated with:

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

Purpose

Topical analgesic

Warnings

For external use only

Directions

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

Active Ingredient

Menthol 5%

Inactive Ingredients (Inactive ingredients)

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

When Using This Product (When using this product)

•
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

Stop Use and Ask A Doctor If (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
•
you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Principal Display Panel – Large Patch (5 Patch Pouch)

MENTHOL 5%

ICY HOT^®

ORIGINAL

Pain Relief Patch

LARGE

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

3-15/16” x 7-13/16” (10 cm x 20 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

Made in Japan

Pouch Label

Principal Display Panel – Large Patch (single Patch Pouch) (Principal Display Panel – Large Patch (Single Patch Pouch))

MENTHOL 5%

ICY HOT^®

ORIGINAL

Pain Relief Patch

LARGE

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 1 Patch

3-15/16” x 7-13/16” (10 cm x 20 cm)

CHATTEM_®

A SANOFI COMPANY

Dist. by Chattem, Inc., a Sanofi Company

P.O. Box 2219

Chattanooga, TN 37409-0219 USA

©2020 www.icyhot.com

Made in Japan

Pouch Label

Advanced Ingredient Data

[{"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "428.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ALUMINUM HYDROXIDE", "unii": "5QB0T2IUN0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NONOXYNOL-30", "unii": "JJX07DG188", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYACRYLIC ACID (250000 MW)", "unii": "9G2MAD7J6W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM POLYACRYLATE (2500000 MW)", "unii": "05I15JNI2J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN SESQUIOLEATE", "unii": "0W8RRI5W5A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TARTARIC ACID", "unii": "W4888I119H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor pain associated with: • arthritis • simple backache • bursitis • tendonitis • muscle strains • sprains • bruises • cramps", "Purpose": "Topical analgesic", "Warnings": "For external use only", "Directions": "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", "Active Ingredient": "Menthol 5%", "Inactive ingredients": "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", "When using this product": "• 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", "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 • you experience signs of skin injury, such as 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. ", "Principal Display Panel – Large Patch (5 Patch Pouch)": "MENTHOL 5% ICY HOT ® ORIGINAL Pain Relief Patch LARGE 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 3-15/16” x 7-13/16” (10 cm x 20 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 Made in Japan Pouch Label", "Principal Display Panel – Large Patch (Single Patch Pouch)": "MENTHOL 5% ICY HOT ® ORIGINAL Pain Relief Patch LARGE 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 1 Patch 3-15/16” x 7-13/16” (10 cm x 20 cm) CHATTEM ® A SANOFI COMPANY Dist. by Chattem, Inc., a Sanofi Company P.O. Box 2219 Chattanooga, TN 37409-0219 USA ©2020 www.icyhot.com Made in Japan Pouch Label"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information