NUVALU ICE THERAPY MENTHOL PAIN RELIEVING (MENTHOL) GEL [JC SALES]

NUVALU ICE THERAPY MENTHOL PAIN RELIEVING (MENTHOL) GEL [JC SALES]
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NDC 72520-112-24
Set ID 7b4dcca8-dc99-0bc5-e053-2991aa0a7582
Category HUMAN OTC DRUG LABEL
Packager JC SALES
Generic Name
Product Class
Product Number
Application Number PART348
  • 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)

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