Label: NUVALU ICE THERAPY MENTHOL PAIN RELIEVING- menthol gel

  • Category: HUMAN OTC DRUG LABEL

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 November 1, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Drug Facts Active Ingredients

    Menthol 1.25 percent

  • Purpose

    Topical Analgesic

  • USE:

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

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

  • 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 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 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 to 4 times daily
  • Inactive Ingredients:

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

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    NUVALU ICE THERAPY MENTHOL PAIN RELIEVING 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72520-112
    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
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CARBOMER 934 (UNII: Z135WT9208)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72520-112-24227 g in 1 JAR; Type 0: Not a Combination Product11/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/01/2018
    Labeler - JC SALES (610969578)
    Registrant - JC SALES (610969578)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Daily Chemical Products Co., Ltd.530766098manufacture(72520-112)
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

More Info on this Drug

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