Icy Hot®

Icy Hot®
SPL v3
SPL
SPL Set ID b11d93b9-39e1-46b5-ae7f-cbb5885e87e2
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 2023-01-31 Until 2026-03-31

Description

Menthol 5%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 5%

Uses

temporarily relieves minor aches and pains of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises
Warnings

For external use only

Directions

children 5 years of age and older:

  • patch may be cut into smaller sizes with scissors prior to removal of the backing
  • 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
  • apply to affected area not more than 3 to 4 times daily
  • wash hands after applying or removing patch. Throw away the patch by folding sticky ends together.

children under 5 years of age: ask a doctor

Do Not Use
  • on wounds or on irritated or damaged skin
  • with a heating pad
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
  • do not bandage tightly
  • avoid contact with eyes and mucous membranes
  • do not expose the area to local heat or to direct sunlight
  • rare cases of serious burns have been reported with products of this type
  • a transient burning sensation may occur upon application but generally disappears in several days
  • avoid applying into skin folds
Stop Use and Ask A Doctor If
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • redness is present or excessive skin irritation occurs
  • your child experiences severe burning 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 – Pouch Label

ICY HOT®

KIDS

PAIN RELIEF

PATCH

FAST ACTING

EASY TO APPLY AND REMOVE

WEAR UP TO 8 HOURS

WITH NATURALLY-SOURCED

MENTHOL 5%

DEVELOPED WITH PEDIATRICIANS

AGES 5+

CONTAINS 5 PATCHES IN ONE RESEALABLE POUCH

3-1/8" x 4-5/8" (8 cm x 12 cm) EACH





PRODUCT SHOULD BE APPLIED UNDER ADULT SUPERVISION

Dist. by Chattem, Inc., a Sanofi Company

P.O. Box 2219

Chattanooga, TN 37409-0219 USA

©2022     www.icyhot.com

Label


Structured Label Content

Uses

temporarily relieves minor aches and pains of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises
Purpose

Topical analgesic

Warnings

For external use only

Directions

children 5 years of age and older:

  • patch may be cut into smaller sizes with scissors prior to removal of the backing
  • 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
  • apply to affected area not more than 3 to 4 times daily
  • wash hands after applying or removing patch. Throw away the patch by folding sticky ends together.

children under 5 years of age: ask a doctor

Do Not Use (Do not use)
  • on wounds or on irritated or damaged skin
  • with a heating pad
Active Ingredient (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
  • do not bandage tightly
  • avoid contact with eyes and mucous membranes
  • do not expose the area to local heat or to direct sunlight
  • rare cases of serious burns have been reported with products of this type
  • a transient burning sensation may occur upon application but generally disappears in several days
  • avoid applying into skin folds
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • redness is present or excessive skin irritation occurs
  • your child experiences severe burning 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 – Pouch Label

ICY HOT®

KIDS

PAIN RELIEF

PATCH

FAST ACTING

EASY TO APPLY AND REMOVE

WEAR UP TO 8 HOURS

WITH NATURALLY-SOURCED

MENTHOL 5%

DEVELOPED WITH PEDIATRICIANS

AGES 5+

CONTAINS 5 PATCHES IN ONE RESEALABLE POUCH

3-1/8" x 4-5/8" (8 cm x 12 cm) EACH





PRODUCT SHOULD BE APPLIED UNDER ADULT SUPERVISION

Dist. by Chattem, Inc., a Sanofi Company

P.O. Box 2219

Chattanooga, TN 37409-0219 USA

©2022     www.icyhot.com

Label


Advanced Ingredient Data


Raw Label Data

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