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Icy Hot Back and Large Areas (Chattem, Inc.)

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PATCH 2 POUCH in 1 CARTON (41167-0073-8) > 5 PATCH in 1 POUCH Label Information

Complete Icy Hot Back and Large Areas Information

  • SPL UNCLASSIFIED SECTION

    Icy Hot® - Medicated Patch

    ARM, NECK & LEG & SMALL AREAS


  • 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
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged skin, broken or irritated skin 

    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

    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 grasping both ends firmly 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 one patch to affected area
    • wear one Icy Hot Patch up to 8 hours
    • repeat as necessary, but no more than 4 times daily

    children 12 years or younger: ask a doctor


  • Inactive Ingredients

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

    KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION FOR USAGE OF THE PRODUCT.

    Distributed by Chattem, Inc.
    P.O. Box 2219
    Chattanooga, TN 37409-0219 USA 
    ©2007 www.icyhot.com  
    Made in Japan.   0049602-01




    Icy Hot® - Medicated Patch

    BACK & LARGE AREAS


  • 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
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged skin 

    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

    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 grasping both ends firmly and gently pulling until backing separates in middle
    • carefully remove backing from patch
    • apply one patch to affected area
    • wear one Icy Hot Patch up to 8 hours
    • repeat as necessary, but no more than 4 times daily

    children 12 years or younger: ask a doctor


  • Inactive Ingredients

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

    Visit us on the web at www.icyhot.com Made in Japan



    Icy Hot® - Medicated Patch

    XL BACK & LARGE AREAS


  • 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
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged skin, broken or irritated skin 

    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

    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 grasping both ends firmly and gently pulling until backing separates
    • 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 one patch to affected area
    • wear one Icy Hot Patch up to 8 hours
    • repeat as necessary, but no more than 4 times daily

    children 12 years or younger: ask a doctor


  • Inactive Ingredients

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

    KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION FOR USAGE OF THE PRODUCT.

    Made in Japan. Visit us on the web at www.icyhot.com 0044855-02




  • Principal Display Panel

    EXTRA STRENGTH
    ICY HOT®  
    MEDICATED PATCH
    Menthol 5%
    ICY to DULL the PAIN – HOT to RELAX it away®
    Lasts up to 8 Hours!
    Small Patch
    3-1/8” x 4-5/8” (8 cm x 12 cm) each
    Pain Relieving Ointment on
    a Breathable Adhesive Pad
    ARM. NECK & LEG
    & SMALL AREAS
    Contains 5 Patches in 1 Resealable Pouch

    Principal Display Panel


  • Principal Display Panel

    EXTRA STRENGTH
    ICY HOT®  
    MEDICATED PATCH
    Menthol 5%
    ICY to DULL the PAIN – HOT to RELAX it away®
    Lasts up to 8 Hours!
    LARGE PATCH
    3-15/16” x 7-13/16” (10 cm x 20 cm) each
    Pain Relieving Ointment on
    a Breathable Adhesive Pad
    BACK
    & LARGE AREAS
    Contains 5 Patches
    In 1 Resealable Pouch

    Principal Display Panel


  • Principal Display Panel

    EXTRA STRENGTH
    ICY HOT®  
    MEDICATED PATCH XL
    Menthol 5%
    ICY to DULL the PAIN – HOT to RELAX it away®
    75 % Larger
    Than Regular Back Patches
    Lasts up to 8 Hours!
    EXTRA LARGE PATCH
    5-1/2” x 9-3/4” (14 cm x 25 cm) each
    Pain Relieving Ointment on
    a Breathable Adhesive Pad
    XL BACK
    & LARGE AREAS
    Contains 3 Patches
    In 1 Resealable Pouch

      Principal Display Panel


  • INGREDIENTS AND APPEARANCE
    ICY HOT ARM NECK LEG AND SMALL AREAS 
    menthol patch
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0084
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 205.50 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ETHYLHEXYL ACETATE (UNII: 2C7K8OA8SB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYL ACRYLATE (UNII: WC487PR91H)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    TALC (UNII: 7SEV7J4R1U)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0084-1 1 in 1 CARTON
    1 5 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 11/01/2000
    ICY HOT BACK AND LARGE AREAS 
    menthol patch
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0843
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 428.50 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ETHYLHEXYL ACETATE (UNII: 2C7K8OA8SB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYL ACRYLATE (UNII: WC487PR91H)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    TALC (UNII: 7SEV7J4R1U)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0843-1 1 in 1 CARTON
    1 5 in 1 POUCH
    2 NDC:41167-0843-7 3 in 1 CARTON
    2 5 in 1 POUCH
    3 NDC:41167-0843-2 1 in 1 CARTON
    3 6 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 03/01/2003
    ICY HOT XL BACK AND LARGE AREAS 
    menthol patch
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0847
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 750.00 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ETHYLHEXYL ACETATE (UNII: 2C7K8OA8SB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYL ACRYLATE (UNII: WC487PR91H)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    TALC (UNII: 7SEV7J4R1U)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0847-1 1 in 1 CARTON
    1 3 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 12/01/2007
    ICY HOT BACK AND LARGE AREAS 
    menthol patch
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0073
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 428.50 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ETHYLHEXYL ACETATE (UNII: 2C7K8OA8SB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYL ACRYLATE (UNII: WC487PR91H)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    TALC (UNII: 7SEV7J4R1U)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0073-8 2 in 1 CARTON
    1 5 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 03/01/2003
    ICY HOT BACK AND LARGE AREAS 
    menthol patch
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0083
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 428.50 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ETHYLHEXYL ACETATE (UNII: 2C7K8OA8SB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYL ACRYLATE (UNII: WC487PR91H)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    TALC (UNII: 7SEV7J4R1U)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0083-2 1 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 03/01/2003
    Labeler - Chattem, Inc. (003336013)