Label: ICEQUAKE COLDN HOT MEDICATED PATCH- menthol cloth

  • NDC Code(s): 69822-014-04
  • Packager: Southern Sales & Service, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • Drug Facts

  • Active ingredient

    Menthol 5%

    Purpose

    Topical analgesic

  • Uses

    Temporarily relieves minor pain associated with: • arthritis • muscle strains • simple backache • bursitis • cramps • tendonitis • muscle sprains • bruises

  • Warnings

    For external use only

    When using this product

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

    do not use

    • if you are allergic to any ingredients of this product

    Stop use and ask a doctor if

    • condition worsens 
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present 
    • irritation develops

    If pregnant or breast-feeding,

    ask a health professional before use

    Keep out of reach of children.

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

  • Directions

    Adults and children over 12 years:

    store at room temperature Children under 12 years of age:

    • Carefully remove backing film from patch
    • Apply one patch to affected area
    • Use one patch at a time, 1 or 2 times a day
  • Other Information

    store at room temperature

  • Inactive Ingredients

    CARBOXYMETHYLCELLULOSE, DIHYDROXYALUMINUM AMINOACETATE, GLYCERIN, KAOLIN, METHYLPARABEN, MINERAL OIL, PETROLATUM, POLYACRYLIC ACID , PROPYLENE GLYCOL, POLYSORBATE 80, POVIDONE, PROPYLPARABEN, SODIUM POLYACRYLATE, TARTARIC ACID, TITANIUM DIOXIDE, WATER

  • Package Labeling:

    RL1

  • INGREDIENTS AND APPEARANCE
    ICEQUAKE COLDN HOT MEDICATED PATCH 
    menthol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69822-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POVIDONE (UNII: FZ989GH94E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69822-014-044 in 1 POUCH11/02/2022
    19.5 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/02/2022
    Labeler - Southern Sales & Service, Inc. (013114906)
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