Icy Hot - Medicated No Mess Applicator

Icy Hot - Medicated No Mess Applicator
SPL v7
SPL
SPL Set ID 4ce2b823-7ef5-4cca-a2d8-2fe781bc958e
Route
TOPICAL
Published
Effective Date 2025-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.16 g)
Inactive Ingredients
Carbomer Interpolymer Type A (55000 Cps) Alcohol Capsaicin Glycerin Isopropyl Myristate Propylene Glycol Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-12-01

Description

Icy Hot ® - Medicated No Mess Applicator

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Icy Hot ® - Medicated No Mess Applicator

Uses

temporarily relieves minor pain associated with:  

  • arthritis

  • simple backache  

  • strains  

  • sprains  

  • bruises  
Section 42229-5

Icy Hot ® - Medicated No Mess Applicator

Warnings

For external use only

Flammable: keep away from heat and open flame.

Directions

■ adults and children 12 years of age and older:

      ■ apply a thin layer to affected area not more than 3 to 4 times daily

      ■ massage until thoroughly absorbed into skin

      ■ wash hands thoroughly with soap and water after each use

■ 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 Ingredient

Menthol 16%

Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat. (30%), capsaicin, glycerin, isopropyl myristate, propylene glycol, triethanolamine, water

Close cap tightly after use.

Principal Display Panel

ICY HOT ®  

ORIGINAL

N
O- MESS

ROLL ON


PAIN RELIEF  

16% MENTHOL

2.5   fl oz ( 73   m L)  

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.


Structured Label Content

Uses

temporarily relieves minor pain associated with:  

  • arthritis

  • simple backache  

  • strains  

  • sprains  

  • bruises  
Section 42229-5 (42229-5)

Icy Hot ® - Medicated No Mess Applicator

Purpose

Topical analgesic

Warnings

For external use only

Flammable: keep away from heat and open flame.

Directions

■ adults and children 12 years of age and older:

      ■ apply a thin layer to affected area not more than 3 to 4 times daily

      ■ massage until thoroughly absorbed into skin

      ■ wash hands thoroughly with soap and water after each use

■ 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 Ingredient (Active ingredient)

Menthol 16%

Inactive Ingredients (Inactive ingredients)

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat. (30%), capsaicin, glycerin, isopropyl myristate, propylene glycol, triethanolamine, water

Close cap tightly after use.

Principal Display Panel

ICY HOT ®  

ORIGINAL

N
O- MESS

ROLL ON


PAIN RELIEF  

16% MENTHOL

2.5   fl oz ( 73   m L)  

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.


Advanced Ingredient Data


Raw Label Data

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