MAXIM ICE COLD ANALGESIC (MENTHOL) OINTMENT [NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.]

MAXIM ICE COLD ANALGESIC (MENTHOL) OINTMENT [NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.]
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NDC 76176-056-01
Set ID 7aaede8e-9e90-57bb-e053-2a91aa0a3d26
Category HUMAN OTC DRUG LABEL
Packager Ningbo Liyuan Daily Chemical Products Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART348
  • Drug Facts Active Ingredients:

    Menthol 1 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 products
    • adults and children 2 years of age and older
    • apply to affected area not more than 3 to 4 times daily
  • Inactive Ingredients:

    carbomer, isopropyl alcohol, nonyl phenyl polyoxyethylene ether, camphor, kathon CG, FD&C blue no.1, triethanolamine, water

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    MAXIM ICE COLD ANALGESIC 
    menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76176-056
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76176-056-01227 g in 1 BOTTLE, PLASTIC; 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 - 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(76176-056)

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