ICY HOT POWER- menthol gel 
Chattem, Inc.

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. Read and follow all directions and warnings on this label.

■ avoid contact with eyes and mucous membranes

rare cases of serious burns have been reported with products of this type

■ do not apply to wounds or damaged, broken or irritated skin

■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use

■ 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

avoid applying into skin folds

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
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

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 a thin layer 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

alcohol denat. (15%), allantoin, aloe barbadensis leaf juice, carbomer, diisopropyl adipate, eucalyptus globulus leaf oil, glycerin, mentha piperita (peppermint) oil, methyl salicylate, steareth-2, steareth-21, thymus vulgaris (thyme) oil, tocopheryl acetate, triethanolamine, water

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

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

www.icyhot.com

Principal Display Panel

ICY HOT®  

Power

Gel

Menthol 16%

NO MESS PAIN RELIEF

MAXIMUM STRENGTH

PAIN RELIEVING GEL

1.75 oz (49 g)

Principal Display Panel
ICY HOT®  
Power
Gel 
Menthol 16%
NO MESS PAIN RELIEF
MAXIMUM STRENGTH
PAIN RELIEVING GEL
1.75 oz (49 g)
Principal Display Panel
ICY HOT®  
Power
Gel 
Menthol 16%
NO MESS PAIN RELIEF
MAXIMUM STRENGTH
PAIN RELIEVING GEL
1.75 oz (49 g)

ICY HOT POWER 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0086
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-21 (UNII: 53J3F32P58)  
THYME OIL (UNII: 2UK410MY6B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0086-049 g in 1 CONTAINER; Type 0: Not a Combination Product12/01/200910/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/01/200910/31/2022
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIBusiness Operations
CHATTEM, INC.830410721label(41167-0086) , manufacture(41167-0086) , pack(41167-0086)
Establishment
NameAddressID/FEIBusiness Operations
CHATTEM, INC.003336013analysis(41167-0086) , label(41167-0086) , manufacture(41167-0086) , pack(41167-0086)

Revised: 5/2023
 
Chattem, Inc.