Label: ICY HOT VANISHING SCENT- menthol gel

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 23, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Menthol 2.5%

  • 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 carton.

    ■ 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

    ■ 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 care 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
    • squeeze desired amount of Icy Hot® pain relieving gel onto affected area
    • using the sponge-top applicator, massage dispensed gel into painful area until thoroughly absorbed
    • repeat as necessary, but not more than 4 times daily

    children 12 years or younger: ask a doctor

  • Inactive ingredients

    alcohol denat. (15%), allantoin, aloe barbadensis leaf juice, carbomer, DMDM hydantoin, glycerin, methylparaben, phenoxyethanol, propylparaben, steareth-2, steareth-21, triethanolamine, water

    Keep carton as it contains important information.

    Close cap tightly after use.

  • PRINCIPAL DISPLAY PANEL

    MENTHOL 2.5%
    NEW LOOK
    ICYHOT® 
    ORIGINAL
    VANISHING SCENT
    PAIN RELIEVING GEL
    Net wt 2.5 oz (70.8 g)

    MENTHOL 2.5% NEW LOOK ICYHOT® ORIGINAL VANISHING SCENT PAIN RELIEVING GEL Net wt 2.5 oz (70.8 g)

  • INGREDIENTS AND APPEARANCE
    ICY HOT VANISHING SCENT 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0092
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.025 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)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0092-01 in 1 CARTON03/01/2007
    171 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/01/2007
    Labeler - Chattem, Inc. (003336013)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHATTEM, INC.830410721manufacture(41167-0092)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHATTEM, INC.003336013manufacture(41167-0092)
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