Label: ICE COLD ANALGESIC- menthol gel

  • 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 August 26, 2011

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  • ACTIVE INGREDIENT



    Active Ingredients:

    Menthol 1%

  • PURPOSE



    Purpose

    Topical analgesic

  • 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.

  • INDICATIONS & USAGE



    Uses for the temporary relief of minor aches and pains in muscles and joints associated with:
    simple backache

    sports injuries

    strains

    arthritis

    sprains

    bruises

  • WARNINGS

    Warnings
    For external use only
    Do not use with other topical pain relievers, with heating pads or heating devices
    When using this product do not use in or near eyes, do not apply to wounds or damaged skin
    do not bandage tightly
    Stop use and ask doctor if condition worsens, symptoms last more than  days or clear up and occur again within a few days, redness or irritation develops
    If pregnant or breast feeding ask a health professional before use.



  • DOSAGE & ADMINISTRATION


    Directions

    Clean affected area before applying product

    adults and children 2 years of age and older; apply to affected area not more than 3-4 times daily


  • INACTIVE INGREDIENT



    Inactive ingredients carbomer, isopropyl alcohol, kathon CG, sodium hydroxide, thymol, water (aqua), FD and C blue no.1

  • PRINCIPAL DISPLAY PANEL

    label


    Personal Care

    Ice cold

    analgesic gel

    New wt. 8 oz. (227 g)

  • INGREDIENTS AND APPEARANCE
    ICE COLD ANALGESIC 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9034
    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)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    THYMOL (UNII: 3J50XA376E)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-9034-6227 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2011
    Labeler - Personal Care Products (966155082)
    Registrant - Personal Care Products (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Daily Chemical Products Co Ltd530766098manufacture
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