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  5. Label Information: Icy Hot Medicated No Mess Applicator

FDA Label for Icy Hot Medicated No Mess Applicator

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. FLAMMABLE
    8. IF PREGNANT OR BREAST-FEEDING
    9. KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. INACTIVE INGREDIENTS
    12. PRINCIPAL DISPLAY PANEL

Icy Hot Medicated No Mess Applicator Product Label

The following document was submitted to the FDA by the labeler of this product Chattem, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

* Please review the disclaimer below.