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
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 10, 2023

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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 not finalpart34805/10/2004
    Labeler - PO SUM ON MEDICINE FACTORY LIMITED (664986395)
    Establishment
    NameAddressID/FEIBusiness Operations
    PO SUM ON MEDICINE FACTORY LIMITED664986395manufacture(54155-052)
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