Icy Hot®

Icy Hot®
SPL v3
SPL
SPL Set ID 0ce4a95a-b739-45a8-a836-3fd6245f3280
Route
TOPICAL
Published
Effective Date 2025-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (180 mg) Menthol, Unspecified Form (300 mg)
Inactive Ingredients
Aluminum Hydroxide Carboxymethylcellulose Sodium, Unspecified Edetate Disodium Anhydrous Glycerin Nonoxynol-30 Polyacrylic Acid (250000 Mw) Polysorbate 80 Propylene Glycol Silicon Dioxide Sodium Polyacrylate (2500000 Mw) Talc Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-31

Description

Camphor 3% Menthol 5%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Camphor 3% 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

adults and children 12 years of age and older:

  • 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 12 years of age: ask a doctor

Do Not Use
  • on wounds or on irritated or damaged skin
  • with a heating pad
Active Ingredients

Camphor 3%

Menthol 5%

Inactive Ingredients

aluminum hydroxide, cellulose gum, disodium EDTA, glycerin, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, propylene glycol, silica, sodium polyacrylate, 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
  • you experience 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®



PRO

PAIN RELIEF

PATCH



WEAR FOR UP

TO 8 HOUR



EXTRA STRENGTH WITH 2 PAIN RELIEVERS



MENTHOL 5%

CAMPHOR 3%



Contains 5 Patches in 1 Resealable Pouch

3-15/16" x 5-1/2" (10 cm x 14 cm) each





SANOFI CONSUMER HEALTH CARE

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

adults and children 12 years of age and older:

  • 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 12 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 Ingredients (Active ingredients)

Camphor 3%

Menthol 5%

Inactive Ingredients (Inactive ingredients)

aluminum hydroxide, cellulose gum, disodium EDTA, glycerin, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, propylene glycol, silica, sodium polyacrylate, 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
  • you experience 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®



PRO

PAIN RELIEF

PATCH



WEAR FOR UP

TO 8 HOUR



EXTRA STRENGTH WITH 2 PAIN RELIEVERS



MENTHOL 5%

CAMPHOR 3%



Contains 5 Patches in 1 Resealable Pouch

3-15/16" x 5-1/2" (10 cm x 14 cm) each





SANOFI CONSUMER HEALTH CARE

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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