Icy Hot Power Gel

Dosage form: gel
Ingredients: MENTHOL 0.16g in 1g
Labeler: Chattem, Inc.
NDC Code: 41167-0086

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Icy Hot - Power Gel

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)

ICY HOT POWER GEL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0086
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
D&C BLUE NO. 1 
GLYCERIN 
PROPYLENE GLYCOL 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:41167-0086-049 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34812/01/2009
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIOperations
Chattem Plant 1003336013ANALYSIS, LABEL, MANUFACTURE, PACK, RECOVERY, RELABEL, REPACK
Establishment
NameAddressID/FEIOperations
Chattem Plant 2830410721LABEL, MANUFACTURE, PACK, RECOVERY, RELABEL, REPACK

Revised: 12/2009
 
Chattem, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)