Label: COOL HOT ICE ANALGESIC GEL- menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 24, 2019

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  • Active Ingredient

    Menthol 1.0%

  • Purpose

    Topical Analgesic

  • Uses:

    • temporary relief of minor aches and pains in muscles and joints associated with simple backaches, strains, sprains, arthritis and sports injuries
  • Warnings

    FOR EXTERNAL USE ONLY

    Use only as directed. Avoid contact with eyes or mucous membranes. Do not apply to open wounds or damaged skin. Make sure skin is clean and free from any creams , ointments , sprays or liniment. Do not bandage.

  • Do not use with heating pads or heating devices

    If condition worsens or symptoms persist for more than 7 days, or if symptoms disappear and occur again within a few days, discontinue use and consult a physician before use. If skin irritation develops, discontinue use and consult a physician. If you are pregnant or nursing a baby, consult your doctor before use. Do not use, store, pour or spoll near heat or open flame. Store in a cool, dry place and keep lid tightly closed.

  • KEEP OUT OF REACH OF CHILDREN

    In case of accidental ingestion, get medical help or contact a Poison Control Center right away

  • Directions

    Clean skin of all other lotions, creams, ointments, liniment, or sprays. Apply liberally to affected area and massage until gel is absorbed into skin. Do not apply more than 3 or 4 times daily. No protective cover needed. Do not apply to children under 2 years or age.

  • Inactive Ingredients

    Water, Isopropyl Alchohol , Nonoxynol-10, Camphor, Carbomer 934, Sodium Hydroxide, Methylchloroisothiazolinone & Methylisothiazolinone, FD&C Blue no. 1

  • PRINCIPAL DISPLAY PANEL

    package label

  • INGREDIENTS AND APPEARANCE
    COOL HOT ICE ANALGESIC GEL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-0201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.27 g  in 227 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER 934 (UNII: Z135WT9208)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52410-0201-2227 g in 1 JAR; Type 0: Not a Combination Product09/21/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/21/2009
    Labeler - SHIELD LINE LLC (078518916)
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