Label: ICY HOT- lidocaine, menthol patch

  • NDC Code(s): 62168-1720-2
  • Packager: Lead Chemical Co. Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 2, 2024

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

  • 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 puncture wounds, cuts, irritated, damaged or swollen skin
    more than 1 patch on your body at a time or with other topical analgesics at the same time
    with a heating pad or apply local heat to the area of use
  • When using this product

    use only as directed
    do not bandage tightly
    avoid contact with the eyes and mucous membranes
    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
    dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
  • 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
    severe burning sensation, redness, or irritation develops
    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 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
    use 1 patch at a time and not more than 3 to 4 times daily

    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

  • Package/Label Principal Display Panel

    LIDOCAINE 4% + MENTHOL 1%

    ICY HOT®
    MAX
    Pain Relief Patch

    LIDOCAINE
    PATCH

    Maximum Strength Lidocaine
    Without a Prescription*
    Penetrates for Fast, Targeted Relief
    Comfortable Fabric
    Stays in Place

    *Among OTC Topical Analgesics
    Contains 1 Patch
    3-15/16” x 5-1/2” (10 cm x 14 cm)

    CHATTEM®
    A SANOFI COMPANY
    Dist. by Chattem, Inc., a Sanofi Company
    P.O. Box 2219
    Chattanooga, TN 37409-0219 USA
    ©2020
    www.icyhot.com     Made in Japan.

    image-01

    Label

  • INGREDIENTS AND APPEARANCE
    ICY HOT 
    lidocaine, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-1720
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE240 mg
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM60 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    UREA (UNII: 8W8T17847W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62168-1720-2400 in 1 CARTON05/10/2021
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/15/2017
    Labeler - Lead Chemical Co. Ltd. (693727091)