Label: ICY HOT MEDICATED- menthol patch
ICY HOT MEDICATED, BACK- menthol patch
ICY HOT MEDICATED, XL- menthol patch
ICY HOT MEDICATED, ADVANCED RELIEF- menthol patch

  • NDC Code(s): 62168-0084-3, 62168-0084-4, 62168-0805-4, 62168-0843-9, view more
    62168-0847-3, 62168-0847-4, 62168-0847-5, 62168-0847-6, 62168-0847-7
  • 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

    Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches

    Menthol 5%

    Icy Hot Advanced Relief Patches

    Menthol 7.5%

  • Purpose

    Topical analgesic

  • Uses

    Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches

    temporarily relieves minor pain associated with:

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

    Icy Hot Advanced Relief Patches

    temporarily relieves minor aches and pains of muscles and joints associated with:

    ▪
    arthritis
    ▪
    simple backache
    ▪
    strains
    ▪
    sprains
    ▪
    bruises
  • Warnings

    For external use only

    Do not use

    Icy Hot Advanced Relief Patches

    ▪
    on wounds or on irritated or damaged skin
    ▪
    with a heating pad

    When using this product

    Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches

    ▪
    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

    Icy Hot Advanced Relief Patches

    ▪
    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

    Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches

    ▪
    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

    Icy Hot Advanced Relief Patches

    ▪
    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

    Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches

    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

    Icy Hot Advanced Relief Patches

    adults and children 12 years of age and older:

    ▪
    clean and dry affected area
    ▪
    gently fold the patch in half to remove center section of film backing. Apply the exposed adhesive portion to the site of pain.
    ▪
    remove remaining film backing from both sides and finish applying to skin
    ▪
    apply to 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: ask a doctor

  • Inactive ingredients

    Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches

    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

    Icy Hot Advanced Relief Patches

    glyceryl hydrogenated rosinate, mineral oil, polyisobutene, styrene/isoprene copolymer

  • Principal Display Panel - Arm, Neck & Leg Pouch

    MENTHOL 5%

    ICY HOT®
    ORIGINAL
    Pain Relief Patch

    ARM, NECK & LEG
    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 5 Patches in 1 Resealable Pouch
    3-1/8" x 4-5/8" (8 cm x 12 cm) each 


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

    Pouch Label – Arm, Neck, & Leg

    Pouch Label - Arm, Neck, & Leg

  • Principal Display Panel – Extra Strength Back and Large Areas

    ICY HOT®

    MEDICATED
    PATCH
    Menthol 5%

    BONUS
    20%
    MORE! one free
    patch inside

    TARGETED
    NO MESS RELIEF

    •
    Stops Pain at
    the Source
    •
    Lasts up to 8 Hours
    •
    Comfortable Fabric
    Stays in Place

    Pain Relieving Ointment
    on a Breathable Adhesive Pad

    EXTRA STRENGTH
    BACK
    and Large Areas

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


    CHATTEM®
    A SANOFI COMPANY
    Distributed by Chattem, Inc., P.O. Box 2219
    Chattanooga, TN 37409-0219 USA
    ©2017     www.icyhot.com

    Pouch Label - Back and Large Areas – Bonus

    Pouch Label - Back and Large Areas – Bonus

  • Principal Display Panel - XL Back

    MENTHOL 5%

    ICY HOT®
    ORIGINAL
    Pain Relief Patch

    XL 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 3 Patches in 1 Resealable Pouch
    5-1/2" x 9-3/4" (14 cm x 25 cm) each


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

    Pouch Label - XL Back

    Pouch Label - XL Back

  • Principal Display Panel - Extra Strength XL Back and Large Areas

    MENTHOL 5%

    ICY HOT®
    ORIGINAL
    Pain Relief Patch

    XL 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 4 Patches in 1 Resealable Pouch
    5-1/2" x 9-3/4" (14 cm x 25 cm) each


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

    image-06

    Pouch Label - XL Back – Bonus

  • Principal Display Panel - Advanced Pain Relief Patch

    MENTHOL 7.5%

    ICY HOT®
    ADVANCED
    Pain Relief Patch

    LARGE PATCH
    MORE PAIN FIGHTING INGREDIENTS*

    ➢
    Fast Acting Powerful Relief
    ➢
    Comfortable Fabric
    ➢
    Stays in Place

    Wear For Up To 8 Hours

    Contains 5 Patches in 1 Resealable Pouch
    3-15/16" x 5-1/2" (10 cm x 14 cm) each

    *Per same size patch vs Icy Hot®
    original strength patch


    Dist. by: Chattem, Inc., a Sanofi Company
    P.O. Box 2219
    Chattanooga, TN 37409-0219 USA
    ©2021     www.icyhot.com

    image-08

    Pouch Label - Advanced Pain Relief Patch

  • INGREDIENTS AND APPEARANCE
    ICY HOT  MEDICATED
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0084
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM205.5 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:62168-0084-3270 in 1 BOX06/09/202106/30/2026
    15 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:62168-0084-4160 in 1 CARTON12/08/2023
    25 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)11/01/2000
    ICY HOT  MEDICATED, BACK
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0843
    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:62168-0843-980 in 1 CARTON10/16/201703/31/2024
    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)03/01/200303/31/2024
    ICY HOT  MEDICATED, XL
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0847
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM750 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:62168-0847-4100 in 1 BOX06/01/201103/31/2024
    1NDC:62168-0847-34 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:62168-0847-5120 in 1 CARTON05/17/202107/31/2026
    23 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:62168-0847-6100 in 1 BOX05/12/202101/31/2025
    34 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:62168-0847-7100 in 1 CARTON09/19/2023
    43 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)12/01/2007
    ICY HOT  MEDICATED, ADVANCED RELIEF
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0805
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM210 mg
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62168-0805-4300 in 1 BOX07/05/202103/31/2024
    15 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)12/01/201203/31/2024
    Labeler - Lead Chemical Co., Ltd. (693727091)
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