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

Full FDA labeling including 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, when using this product, stop use and ask a doctor if, flammable, 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  
  • muscle strains  
  • sprains  
  • bruises  
  • cramps

Warnings

For external use only

When Using This Product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if severe burning sensation occurs, discontinue use immediately
  • do not expose the area treated with product to heat or direct sunlight

Stop Use And Ask A Doctor If

  • condition worsens
  • redness is present  
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Flammable

  • keep away from fire or flame

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 over 12 years:

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 3-4 times daily
  • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

    • children 12 years or younger: ask a doctor

Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, capsaicin, glycerin, isopropyl myristate, propylene glycol, SD alcohol 40 (30%), water (245-256)

Close cap tightly after use. Keep carton as it contains important information.

Distributed by Chattem, Inc.

P.O. Box 2219

Chattanooga, TN 37409-0219

U.S.A ©2010 www.icyhot.com             Recyclable Carton

Principal Display Panel

ICY HOT®  

MEDICATED

NO MESS

APPLICATOR

Menthol 16%

LONG LASTING

PAIN RELIEF

  • Powerful, Fast
    Acting Formula
  • Roller Ball Keeps
    Hands Clean
  • Quick Drying,
    Stain-Free

    • MAXIMUM STRENGTH

    PAIN RELIEVING LIQUID

    2.5 fl oz (73 mL)

    Principal Display Panel (Icy Hot Medicated No Mess Applicator 01)

    Principal Display Panel (Icy Hot Medicated No Mess Applicator 01)

* Please review the disclaimer below.