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
  • 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 29, 2021

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

  • 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 not finalpart34803/01/2016
    Labeler - Chattem, Inc. (003336013)