icy hot®

icy hot®
SPL v13
SPL
SPL Set ID d4e13689-8973-4041-9f33-e710547dcdee
Route
topical
Published
Effective Date 2025-04-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol, unspecified form (205.5 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 completed Since 2007-12-01 Until 2026-07-31

Purpose

Topical analgesic

Description

Icy Hot Arm, Neck and Leg Patches; and Icy Hot XL Patches Menthol 5%


Medication Information

Warnings

For external use only

Uses

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

temporarily relieves minor pain associated with:

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

Topical analgesic

Directions

Icy Hot Arm, Neck and Leg 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

Inactive Ingredients

Icy Hot Arm, Neck and Leg 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

Description

Icy Hot Arm, Neck and Leg Patches; and Icy Hot XL Patches Menthol 5%

Active Ingredient

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

Menthol 5%

When Using This Product

Icy Hot Arm, Neck and Leg 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
Stop Use and Ask A Doctor If

Icy Hot Arm, Neck and Leg 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
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 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

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


Structured Label Content

Warnings

For external use only

Uses

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

temporarily relieves minor pain associated with:

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

Topical analgesic

Directions

Icy Hot Arm, Neck and Leg 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

Inactive Ingredients (Inactive ingredients)

Icy Hot Arm, Neck and Leg 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

Active Ingredient

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

Menthol 5%

When Using This Product (When using this product)

Icy Hot Arm, Neck and Leg 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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Icy Hot Arm, Neck and Leg 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
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 Xl Back (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

Principal Display Panel Arm, Neck & Leg Pouch (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


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