Label: ICE COLD ANALGESIC- menthol gel

  • NDC Code(s): 76176-066-01
  • 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, 2020

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  • Active ingredient

    Menthol 1 percentage

  • Purpose

    Topical analgesic

  • Uses

    temporarily relieves minor aches and pains of muscles and joints associated with:

    • arthritis
    • simple backache
    • strains
    • bruises
    • sports injuries
    • sprains
    • provides cooling penetrating relief
  • 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 the eyes

    do not apply to wounds or damaged skin

    do not bandage tightly

  • Stop use and ask a doctor if

    condition worsens

    symptoms last more than 7 days or clear up and occur again within a few days

    skin 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 Poison Control Center right away.

  • 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.

    children under 2 years of age: ask a doctor

  • Other information

    • store at controlled room temperature 20 to 25 degrees Celsius (68 to 77 Fahrenheit) in a tightly closed container
    • do not use, pour, spill or store near heat or open flame
  • Inactive ingredients

    Water (Aqua), Camphor, Carbomer, FD&C Blue No.1, Isopropyl Alcohol, Methylchoroisothiazolinone, Methylisothiazolinone, Triethanolamine.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ICE COLD ANALGESIC 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76176-066
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 934 (UNII: Z135WT9208)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76176-066-01227 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2020
    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(76176-066)
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