Label: ICY HOT WITH LIDOCAINE PAIN RELIEVING- lidocaine hcl and menthol cream

  • NDC Code(s): 41167-1710-0, 41167-1710-2
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2023

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  • SPL UNCLASSIFIED SECTION

    ICY HOT®  with LIDOCAINE

    PAIN RELIEVING CREAM

    Drug Facts

  • Active Ingredients

    Lidocaine HCl 4%

  • Purposes

    Topical anesthetic

  • Active Ingredients

    Menthol 1 %

  • Purposes

    Topical analgesic

  • Uses

    Temporarily relieves minor pain

  • Warnings

    For external use only

    Do not use

    • on large areas of the body or on cut, irritated or swollen skin
    • on puncture wounds
    • for more than one week without consulting a doctor

    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) to the area of use
    • do not use at the same time as other topical analgesics  
    • 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 professional before use.

    Keep out of reach of children and pets.

    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 every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
    • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

    children 12 years or younger: ask a doctor

  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat. (15%), aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, methylparaben, polysorbate 60, steareth-21, water

    Keep Carton As It Contains Important Information

    Close cap tightly between uses.

  • PRINCIPAL DISPLAY PANEL

    ICY HOT
    MAX
    LIDOCAINE
    PAIN RELIEF CREAM
    Net Wt 2.7 OZ (76.5 g)

    ICY HOT MAX LIDOCAINE PAIN RELIEF CREAM Net Wt 2.7 OZ (76.5 g)

  • INGREDIENTS AND APPEARANCE
    ICY HOT WITH LIDOCAINE  PAIN RELIEVING
    lidocaine hcl and menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-1710
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.4 g  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARETH-21 (UNII: 53J3F32P58)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-1710-21 in 1 CARTON03/01/2016
    149.6 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:41167-1710-01 in 1 CARTON03/01/2016
    276.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/01/2016
    Labeler - Chattem, Inc. (003336013)
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