Label: HOT ICE SOOTHING 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 September 20, 2009

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  • SPL UNCLASSIFIED SECTION

  • Active Ingredients 

    Menthol             1.0%

  • Purpose

    Topical Analgesic

  • Uses

    Provides temporary relief of minor aches and pains in muscles and joints associated with simple backache strains, sprains, arthritis and sports injuries

  • Warnings

    For external use only. Not for internal use.

    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.

    It 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. If you have sensitive skin, 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 spill near heat or open flame. Store in a cool, dry place and keep lid tightly closed.

  • 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 of age.

  • Other Ingredients

    Water, Isopropyl Alcohol, Nonoxynol-10, Camphor, Carbomer, Sodium Hydroxide, Methylchloroisothiazolinone & Methylisothiazolinone, Blue 1

  • Principal Display Panel

    Perfect Purity

    HotIce

    Soothing analgesic gel

    Fast, temporary relief from muscle aches and pains

    • greaseless
    • analgesic

    NET WT. 8 OZ. (227 g)

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    HOT ICE SOOTHING ANALGESIC GEL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34954-013
    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
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CAMPHOR (UNII: 5TJD82A1ET)  
    CARBOMER 934 (UNII: Z135WT9208)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34954-013-07227 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34109/21/2009
    Labeler - Kim Chemicals LTD (650470164)
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