Label: U ICE COLD- menthol ointment

  • NDC Code(s): 52000-045-01
  • Packager: UNIVERSAL DISTRIBUTION CENTER LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 1, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • 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:

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    U ICE COLD 
    menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-045
    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)  
    WATER (UNII: 059QF0KO0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER 934 (UNII: Z135WT9208)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-045-01227 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 DrugM01708/01/2018
    Labeler - UNIVERSAL DISTRIBUTION CENTER LLC (019180459)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!