U ICE COLD (MENTHOL) OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]

U ICE COLD (MENTHOL) OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]
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NDC 52000-045-01
Set ID 752ef0cd-f12a-3b9e-e053-2991aa0abeb1
Category HUMAN OTC DRUG LABEL
Packager UNIVERSAL DISTRIBUTION CENTER LLC
Generic Name
Product Class
Product Number
Application Number PART348
  • Drug Facts Active Ingredients:

    Menthol 1 percent...............................................Topical Analgesic

    Camphor 0.5 percent.........................................Topical Analgesic

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  • PURPOSE

    Topical Analgesic

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  • Uses:

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

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

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  • Warnings: External Use Only

    For external use only.

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  • Do not use

    with other topical pain relievers

    with heating pads or heating devices

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  • When using this product:

    • Do not use in or near eyes
    • Do not apply to wounds or damaged skin
    • Do not bandage tightly
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  • 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
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  • If pregnant or breast-feeding,

    ask a health professional before use

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  • Keep out of reach of children.

    If swallowed, get medical help or contact a Posion Control Center immediately.

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  • 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
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  • Inactive Ingredients:

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

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  • INGREDIENTS AND APPEARANCE
    U ICE COLD 
    menthol ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-045
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275) CAMPHOR, (-)- 0.5 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
    WATER (UNII: 059QF0KO0R)  
    METHYL ALCOHOL (UNII: Y4S76JWI15)  
    CARBOMER 934 (UNII: Z135WT9208)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52000-045-01 227 g in 1 TUBE; Type 0: Not a Combination Product 08/01/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 08/01/2018
    Labeler - UNIVERSAL DISTRIBUTION CENTER LLC (019180459)
    Registrant - UNIVERSAL DISTRIBUTION CENTER LLC (019180459)
    Establishment
    Name Address ID/FEI Business Operations
    Ningbo Liyuan Daily Chemical Products Co., Ltd. 530766098 manufacture(52000-045)
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