Label: ICEQUAKE COLDN HOT MEDICATED- menthol patch

  • NDC Code(s): 69822-012-01
  • Packager: Southern Sales & Service, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 11, 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 srains
    • 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 contact a Poison Control Center right away

    Directions

    Adults and children over 12 years

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

    Children under 12 years of age

    Consult a physician

    Other information

    store at room temperature

    Inactive Ingredients

    aluminum glycinate, castor oil, concentrate glycerin, disodium edetate hydrate, gelatin, glycol salicylate, isopropyl myristate, mentha oil, polysorbate 80, polyvinyl alcohol, polyvinylpyrrolidone, purified water, sodium polyacrylate, tataric acid, titanium oxide

  • IceQuake Coldn Hot Medicated Patch 69822-010-04

    Bottle label

  • INGREDIENTS AND APPEARANCE
    ICEQUAKE COLDN HOT MEDICATED 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69822-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCOL SALICYLATE (UNII: 3I1VBB7AXH)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69822-012-014 in 1 PACKAGE03/01/201908/31/2025
    11 in 1 PACKET
    19.5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/201908/31/2025
    Labeler - Southern Sales & Service, Inc. (013114906)
    Registrant - Southern Sales & Service, Inc. (013114906)
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