Label: PO SUM ON MEDICATED- menthol oil

  • NDC Code(s): 54155-052-01, 54155-052-02
  • Packager: PO SUM ON MEDICINE FACTORY LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 25, 2024

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  • ACTIVE INGREDIENT

    Active ingredients
    Menthol 15%

  • PURPOSE

    Purpose
    External analgesic

  • INDICATIONS & USAGE

    Uses
    For the temporary relief of minor aches and pains of muscles and joints due to:
    simple backache
    arthritis
    strains
    bruises
    sprains

  • WARNINGS

    Warnings
    For external use only

  • DO NOT USE

    Do not use
    on wounds
    on damaged skin
    if excessive irritation develops

  • WHEN USING

    When using this product
    avoid contact with the eyes
    do not bandage tightly

  • STOP USE

    Stop use and ask a doctor if
    condition worsens
    symptoms persist for more than 7 days
    symptoms clear up and occur again within a few days
    when using for pain of arthritis if:
    pain persists for more than 10 days
    redness is present
    in conditions affecting children under 12 years of age

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions
    Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    Children under 2 years of age: Do not use, consult your doctor

  • STORAGE AND HANDLING

    Other information
    keep container tightly closed
    store at 15∫ to 30C (59 to 86F)

  • INACTIVE INGREDIENT

    Inactive ingredients
    BaikaL Skullcap (Huang-Qin) Root, Chinese Licorice (Gan-Zao) Root, Cinnamon Oil, Dragon’s Blood (Xue-Jie) Resin, Peppermint Oil, and Tea Oil.

  • QUESTIONS

    Questions or comments? (888)221-3496 M-F 9am to 5pm
    you may also report serious side effects to this phone number

  • PRINCIPAL DISPLAY PANEL

    PO SUM ON MEDICATED OIL, EXTERNAL ANALGESIC, NDC 54155-052-01 Net wt. 1 fl. oz (30ml.)IMAGE OF CARTON 30ML

    PO SUM ON MEDICATED OIL, EXTERNAL ANALGESIC, NDC 54155-052-02, FREE SAMPLE, NOT FOR RESALE, 0.19 fl. oz (5.6 ML)IMAGE OF CARTON 5.6ML

    IMAGE OF CARTON 30MLIMAGE OF CARTON 5.6ML

  • INGREDIENTS AND APPEARANCE
    PO SUM ON MEDICATED 
    menthol oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54155-052
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    GLYCYRRHIZA URALENSIS WHOLE (UNII: 8XW1DS8UIR)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    DAEMONOROPS DRACO RESIN (UNII: 787Z7N9UCU)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CAMELLIA OIL (UNII: T1PE06G0VE)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54155-052-011 in 1 CAN05/10/2004
    130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    2NDC:54155-052-021 in 1 BOX05/10/2004
    25.6 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drugpart34805/10/2004
    Labeler - PO SUM ON MEDICINE FACTORY LIMITED (664986395)
    Establishment
    NameAddressID/FEIBusiness Operations
    PO SUM ON MEDICINE FACTORY LIMITED664986395manufacture(54155-052)
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