ICY HOT POWER- menthol gel

Icy Hot Power by

Drug Labeling and Warnings

Icy Hot Power by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc., Chattem Plant 1, Chattem Plant 2. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Icy Hot® - Power Gel

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

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, blue 1, glycerin, hydroxypropyl methylcellulose, propylene glycol, SD alcohol 40-2 (30%), triethanolamine, water (283-027)

Dist. by Chattem, Inc., P.O. Box 2219

Chattanooga, TN 37409-0219, U.S.A ©2009

www.icyhot.com

Principal Display Panel

NEW!

ICY HOT®  

Power

Gel

Menthol 16%

NO MESS PAIN RELIEF

MAXIMUM STRENGTH

PAIN RELIEVING GEL

1.75 oz (49 g)

INGREDIENTS AND APPEARANCE

ICY HOT POWER 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0086
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 g

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0086-0	49 g in 1 CONTAINER; Type 0: Not a Combination Product	12/01/2009

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(41167-0086) , LABEL(41167-0086) , MANUFACTURE(41167-0086) , PACK(41167-0086)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 2		830410721	LABEL(41167-0086) , MANUFACTURE(41167-0086) , PACK(41167-0086)