Label: DORFLEX ICY HOT FLEXIBLE, SMALL- menthol patch
DORFLEX ICY HOT FLEXIBLE, LARGE- menthol patch

  • NDC Code(s): 62168-0085-3, 62168-0086-6
  • Packager: Lead Chemical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 25, 2024

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  • Active Ingredient

    Menthol 5%

  • Purpose

    Topical analgesic

  • Uses

    Dorflex Icy Hot is indicated for bruises, traumas, muscle pains, cramps, torticollis and painful and inflammatory processes at large.

  • Warnings

    For external use only

    For use in adults and children over 12 years.

    When using this product

    •
    Use only as directed.
    •
    Do not use with a heating pad.
    •
    Avoid contact with eyes and mucous membranes.
    •
    Do not apply to wounds or damaged, broken or irritated skin.

    Stop use and ask a doctor if

    •
    Condition worsens.
    •
    Irritation or redness 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 doctor before use.

    Keep out of reach of children.

    If swallowed by accident, get medical help.

  • Directions

    •
    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

    Children 12 years or younger, ask a doctor

  • Precautions

    •
    Do not wear the same patch for more than 8 hours.
    •
    Do not wear more than 3 patches daily.
    •
    Store in ambient temperature.
    •
    Use each patch only once.
  • 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

  • Other Information

    Responsible pharmacist: Mauricio R. Marante - CRF-SP 28.847. ANVISA Registration No. 81807850002

    Manufactured by: Lead Chemical Company, Ltd., 77-3 Himata, Toyama City, 930-0912. Toyama, Japan. Packaged by: Chattem, Inc., 1715 West 38th Street, Chattanooga, Tennessee, 37409. United States. Imported by: Sanofi Medley Farmaceutica Ltda. Rua Conde domingos Papaiz, 413 - Suzano - SP - CEP 08613- 901. CNPJ 10.588.595/0010-92.

  • Principal Display Panel - Small

    Dorflex ICY HOT® Flexible Patch

    •
    Muscle pain
    •
    Bruises
    •
    Cramps
    •
    Torticollis

    Lasts up to 8 hours

    Contains 5 Patches in 1 Resealable Pouch

    Cut open pouch and remove pad

    Reseal pouch after opening

    image-01

    Pouch Label - Small

  • Principal Display Panel - Large

    Dorflex ICY HOT® Flexible Patch

    •
    Muscle pain
    •
    Bruises
    •
    Cramps
    •
    Torticollis

    Lasts up to 8 hours

    Contains 5 Patches in 1 Resealable Pouch

    Cut open pouch and remove pad

    Reseal pouch after opening

    image-03

    Pouch Label - Large

  • INGREDIENTS AND APPEARANCE
    DORFLEX ICY HOT  FLEXIBLE, SMALL
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0085
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL205.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYL ACRYLATE (UNII: WC487PR91H)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62168-0085-3270 in 1 BOX04/22/202110/31/2024
    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)07/01/201310/31/2024
    DORFLEX ICY HOT  FLEXIBLE, LARGE
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0086
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL428.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYL ACRYLATE (UNII: WC487PR91H)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62168-0086-6100 in 1 BOX09/20/202011/30/2024
    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)07/01/201311/30/2024
    Labeler - Lead Chemical Co., Ltd. (693727091)
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