Label: ICY HOT VANISHING SCENT- 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 March 1, 2007

If you are a consumer or patient please visit this version.

  • 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 a thin layer 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

    ICYHOT® 
    ORIGINAL

    VANISHING SCENT
    PAIN RELIEVING GEL
    Menthol 2.5%

    Net wt 2.5 oz (70.8 g)

    ICYHOT® 
ORIGINAL
VANISHING SCENT 
PAIN RELIEVING GEL
Menthol 2.5%
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 NOT FINALpart34803/01/2007
    Labeler - Chattem, Inc. (003336013)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHATTEM, INC.003336013MANUFACTURE(41167-0092)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHATTEM, INC.830410721MANUFACTURE(41167-0092)