ICY HOT MEDICATED NO MESS APPLICATOR- menthol liquid

Icy Hot Medicated No Mess Applicator by

Drug Labeling and Warnings

Icy Hot Medicated No Mess Applicator by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc., CHATTEM, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Icy Hot® - Medicated No Mess Applicator

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)

INGREDIENTS AND APPEARANCE

ICY HOT MEDICATED NO MESS APPLICATOR 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0091
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.16 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAPSAICIN (UNII: S07O44R1ZM)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0091-0	1 in 1 CARTON	12/01/2009
1		73 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	12/01/2009

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 1		003336013	ANALYSIS(41167-0091) , LABEL(41167-0091) , MANUFACTURE(41167-0091) , PACK(41167-0091)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 2		830410721	LABEL(41167-0091) , MANUFACTURE(41167-0091) , PACK(41167-0091)