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Icy Hot Power Gel (Chattem, Inc.)

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GEL 49 g in 1 CONTAINER (41167-0086-0) Label Information

Complete Icy Hot Power Gel Information

  • 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)

    Principal Display Panel


  • INGREDIENTS AND APPEARANCE
    ICY HOT POWER GEL 
    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
    D&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
    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, LABEL, MANUFACTURE, PACK, RECOVERY, RELABEL, REPACK
    Establishment
    Name Address ID/FEI Business Operations
    Chattem Plant 2 830410721 LABEL, MANUFACTURE, PACK, RECOVERY, RELABEL, REPACK