Label: ICY HOT LIDOCAINE NO-MESS- lidocaine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 1, 2023

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  • SPL UNCLASSIFIED SECTION

    ICY HOT with LIDOCAINE CREAM (MAX)

    Drug Facts

  • Active ingredient

  • Purpose

    Lidocaine HCl 4%............................................................................................................................Topical anesthetic

  • Use

    for the temporary relief of pain

  • Warnings

    For external use only

    Flammable

     ■ keep away from heat and open flame.

    Do not use

    ■ in large quantities 

    ■ on wounds or on irritated or damaged skin

    ■ with a heating pad

    When using this product

    ■ use only as directed

    ■ do not bandage tightly

    ■ avoid contact with eyes and mucous membranes

    ■ do not expose the area to local heat or to direct sunlight

    Stop use and ask a doctor if

    ■ condition worsens or symptoms persist for more than 7 days

    ■ symptoms clear up and occur again within a few days

    ■ redness is present or excessive skin irritation occurs

    ■ you experience severe burning 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.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ adults and children 12 years of age and older:

            ■ apply a thin layer to affected area every 6 to 8 hours, not more than 3 to 4 times daily

            ■ massage until thoroughly absorbed into skin

            ■ wash hands thoroughly with soap and water after each use

    ■ children under 12 years of age: 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-2, steareth-21, water

    333-104

    Child-resistant packaging. Close cap tightly after use.

    Keep carton as it contains important information.

  • PRINCIPAL DISPLAY PANEL

    Lidocaine 4%
    IcyHot
    Max

    PRINCIPAL DISPLAY PANEL Lidocaine 4% IcyHot Max
  • INGREDIENTS AND APPEARANCE
    ICY HOT LIDOCAINE NO-MESS 
    lidocaine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-1711
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    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-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-1711-042.5 g in 1 BOTTLE; Type 0: Not a Combination Product02/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/10/2022
    Labeler - Chattem, Inc. (003336013)
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