Icy Hot Medicated No Mess Applicator Liquid
FDA Label NDC 41167-0091

12 label sections · Submitted to the FDA by Chattem, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Icy Hot Medicated No Mess Applicator (NDC 41167-0091). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Menthol 16%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:  

  • arthritis
  • simple backache  
  • strains  
  • sprains  
  • bruises  

Warnings

For external use only

Flammable: keep away from heat and open flame.

Do Not Use

■ on wounds or on irritated or damaged skin

■ with a heating pad

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.

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

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
NO-MESS
ROLL ON
PAIN RELIEF 
16% MENTHOL

2.5 fl oz (73 mL) 

Icy Hot® Originalno-mess Roll Onpain Relief 16% Menthol2.5 Fl Oz (73 mL) (Icy Hot Medicated No Mess Applicator 01)

Icy Hot® Originalno-mess Roll Onpain Relief 16% Menthol2.5 Fl Oz (73 mL) (Icy Hot Medicated No Mess Applicator 01)

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