Label: ICY HOT WITH LIDOCAINE- lidocaine and menthol patch

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

Drug Label Information

Updated January 1, 2025

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  • SPL UNCLASSIFIED SECTION

    ICY HOT with 4% LIDOCAINE PATCH

    Drug Facts

  • Active ingredients 

    Lidocaine 4%

    Menthol 1%

  • Purposes

    Topical anesthetic

    Topical analgesic

  • Use

    for the temporary relief of pain

  • Warnings

    For external use only

    Do not use

    ■ on wounds or on irritated or damaged skin

    ■ more than 1 patch on your body at a time or with other topical analgesics at the same time

    ■ 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

    ■ rare cases of serious burns have been reported with products of this type

    ■ 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 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 and pets.

    Used patches may still contain the drug product that can produce serious adverse effects if ingested by children or pets. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 12 years of age and older:

    ■ clean and dry affected area

    ■ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle

    ■ carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area

    ■ once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area

    ■ apply to the affected area not more than 3 to 4 times daily

    ■ wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. 

    children under 12 years of age: consult a doctor

  • Inactive ingredients

    aluminum glycinate, aluminum hydroxide, cellulose gum, glycerin, methyl acrylate/2-ethylhexyl acrylate copolymer, methylparaben, nonoxynol-30, polyacrylic acid, polysorbate 80, propylene glycol, silica, sodium polyacrylate, tartaric acid, titanium dioxide, urea, water

    Child-resistant packaging.

    Keep carton as it contains important information.

  • PRINCIPAL DISPLAY PANEL

    ICYHOT
    with LIDOCAINE
    LARGE PATCH
    PAIN RELIEF
    4% LIDOCAINE +
    1% MENTHOL

    ICYHOT with LIDOCAINE LARGE PATCH PAIN RELIEF 4% LIDOCAINE + 1% MENTHOL

  • INGREDIENTS AND APPEARANCE
    ICY HOT WITH LIDOCAINE 
    lidocaine and menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-1720
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE240 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL60 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM GLYCINATE (UNII: 1K713C615K)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CELLULOSE GUM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    UREA (UNII: 8W8T17847W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-1720-15 in 1 CARTON; Type 0: Not a Combination Product02/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)02/18/2018
    Labeler - Chattem, Inc. (003336013)
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