Label: U ICE COLD- menthol ointment

  • NDC Code(s): 76176-045-01
  • Packager: Ningbo Liyuan Daily Chemical Products Co., Ltd.
  • 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 1, 2018

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  • Drug Facts Active Ingredients:

    Menthol 1 percent...............................................Topical Analgesic

    Camphor 0.5 percent.........................................Topical Analgesic

  • PURPOSE

    Topical Analgesic

  • Uses:

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

    simple backache, strains, sprains, sports injuries, arthritis, bruises

  • Warnings: External Use Only

    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 7 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

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Posion Control Center immediately.

  • Directions

    • clean affected area before applying products
    • adults and children 2 years of age and older
    • apply to affected area not more than 3 to 4 times daily
  • Inactive Ingredients:

    Water(Aqua), Ethyl Alcohol, Carbomer, Methylchloroisothiazolinone, Methylisothiazolinone, Triethanolamine, FD&C Blue No. 1

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    U ICE COLD 
    menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76176-045
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275) CAMPHOR, (-)-0.5 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
    WATER (UNII: 059QF0KO0R)  
    METHYL ALCOHOL (UNII: Y4S76JWI15)  
    CARBOMER 934 (UNII: Z135WT9208)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76176-045-01227 g in 1 TUBE; Type 0: Not a Combination Product08/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2018
    Labeler - Ningbo Liyuan Daily Chemical Products Co., Ltd. (530766098)
    Registrant - Ningbo Liyuan Daily Chemical Products Co., Ltd. (530766098)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Daily Chemical Products Co., Ltd.530766098manufacture(76176-045)
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