Label: ICE EXTERNAL ANALGESIC LEADER- 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 January 11, 2011

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  • ACTIVE INGREDIENT

    Menthol 2.0%

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with:  simple backache, arthritis, strains, bruises, and sprains.

  • WARNINGS

    Warnings

    For external use only.  When using this product: avoid contact with the eyes, do not bandage tightly, do not apply to wounds or damaged skin, and do not use with heating pads of other heating devices. Stop use and ask doctor if:  condition gets worse, symptoms last more than 7 days, or symptoms clear up and occur again in a few days. 

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 2 years of age and older:  apply to affected area not more than 3 to 4 times daily.  Children under 2 years of age: do not use, consult a doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe Barbadensis Leaf Juice, SD Alcohol 40, Propylene Glycol, Glycerin, Simethicone, Tocopheryl Acetate, Triethanolamine, Carbomer, Diazolidinyl Urea, Methylparaben, Propylparaben, Disodium Cocoamphodipropionate, Disodium EDTA.

  • PURPOSE

    Purpose

    Pain relieving gel.


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • PRINCIPAL DISPLAY PANEL

    Ice Gel External Analgesic.

    Jar image

  • INGREDIENTS AND APPEARANCE
    ICE EXTERNAL ANALGESIC  LEADER
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-616
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol.02 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Ammonia (UNII: 5138Q19F1X)  
    Carbomer 934 (UNII: Z135WT9208)  
    Cupric Sulfate (UNII: LRX7AJ16DT)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Magnesium Sulfate (UNII: DE08037SAB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Thymol (UNII: 3J50XA376E)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-616-34227 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34812/01/2011
    Labeler - Cardinal Health (097537435)
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