Label: ICY HOT MEDICATED, BACK- menthol patch

  • NDC Code(s): 62168-0856-1
  • Packager: Lead Chemical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 4, 2024

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  • Active ingredient

    Menthol 5%

  • Purpose

    Topical analgesic

  • Uses

    temporarily relieves minor pain associated with:

    ▪
    arthritis
    ▪
    simple backache
    ▪
    bursitis
    ▪
    tendonitis
    ▪
    muscle strains
    ▪
    sprains
    ▪
    bruises
    ▪
    cramps
  • Warnings

    For external use only

    When using this product

    ▪
    use only as directed. Read and follow all directions and warnings on this label.
    ▪
    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
    ▪
    a transient burning sensation may occur upon application but generally disappears in several days

    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.

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

  • Directions

    adults and children over 12 years:

    ▪
    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
    ▪
    wear one Icy Hot patch for up to 8 hours
    ▪
    repeat as necessary, but no more than 3 times daily

    children 12 years or younger: ask a doctor

  • Inactive ingredients

    aluminum hydroxide, cellulose gum, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water

  • Principal Display Panel - Large Patch (6 Patch Pouch)

    MENTHOL 5%

    ICY HOT®
    ORIGINAL
    Pain Relief Patch

    LARGE
    PATCH

    FEEL IT WORKING
    INSTANTLY

    ➢
    Powerful Targeted Relief
    ➢
    Icy to Dull, Hot to Relax
    ➢
    Comfortable Fabric
    ➢
    Stays in Place

    Wear For Up To 8 Hours

    Contains 6 Patches in 1 Resealable Pouch
    3-15/16” x 7-13/16” (10 cm x 20 cm) each


    CHATTEM®
    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

    Pouch Label

  • INGREDIENTS AND APPEARANCE
    ICY HOT  MEDICATED, BACK
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0856
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM428.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    TALC (UNII: 7SEV7J4R1U)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62168-0856-180 in 1 CARTON03/31/202102/28/2025
    16 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)03/31/202102/28/2025
    Labeler - Lead Chemical Co., Ltd. (693727091)
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