Label: ICY HOT POWER- menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated December 1, 2009

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  • 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. 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)

  • INGREDIENTS AND APPEARANCE
    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 Product12/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34812/01/2009
    Labeler - Chattem, Inc. (003336013)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHATTEM, INC.003336013ANALYSIS(41167-0086) , LABEL(41167-0086) , MANUFACTURE(41167-0086) , PACK(41167-0086)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHATTEM, INC.830410721LABEL(41167-0086) , MANUFACTURE(41167-0086) , PACK(41167-0086)
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