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Ice Cold Analgesic (Personal Care Products)

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GEL 227 g in 1 JAR (29500-9034-6) Label Information

Complete Ice Cold Analgesic Information

  • ACTIVE INGREDIENT



    Active Ingredients:

    Menthol 1%


  • PURPOSE



    Purpose

    Topical analgesic


  • KEEP OUT OF REACH OF CHILDREN



    Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.


  • INDICATIONS & USAGE



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

    sports injuries

    strains

    arthritis

    sprains

    bruises


  • WARNINGS

    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  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.




  • DOSAGE & ADMINISTRATION


    Directions

    Clean affected area before applying product

    adults and children 2 years of age and older; apply to affected area not more than 3-4 times daily



  • INACTIVE INGREDIENT



    Inactive ingredients carbomer, isopropyl alcohol, kathon CG, sodium hydroxide, thymol, water (aqua), FD and C blue no.1


  • PRINCIPAL DISPLAY PANEL

    label


    Personal Care

    Ice cold

    analgesic gel

    New wt. 8 oz. (227 g)


  • INGREDIENTS AND APPEARANCE
    ICE COLD ANALGESIC 
    menthol gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-9034
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.27 g  in 227 g
    Inactive Ingredients
    Ingredient Name Strength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    THYMOL (UNII: 3J50XA376E)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:29500-9034-6 227 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 03/01/2011
    Labeler - Personal Care Products (966155082)
    Registrant - Personal Care Products (966155082)
    Establishment
    Name Address ID/FEI Business Operations
    Ningbo Liyuan Daily Chemical Products Co Ltd 530766098 manufacture