Label: PLASTER MANDAHERBALPLASTER- menthol patch

  • 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 June 8, 2011

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients: (each 5 g patch contains)                                 PURPOSE
    METHYL SALICYLATE  250 mg                                         EXTERNAL ANALGESIC
    L-METHENOL -  200 mg                                                    EXTERNAL ANALGESIC
    CAMPHOR –   40mg                                                         EXTERNAL ANALGESIC
    SESAME OIL – 500 mg                                                     EXTERNAL ANALGESIC
    MYRRH – 150mg                                                              EXTERNAL ANALGESIC                                     
                                      

  • INDICATIONS & USAGE

    for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis strains, bruises and sprains.

  • WARNINGS

    For external use only

  • DOSAGE & ADMINISTRATION

    Remove the clear backing and apply to thew sore area of skin.

  • STORAGE AND HANDLING

    ■ Keep container tightly closed, once opened, fold the opening and keep pressed closed with a clip.
    ■ Store at room temperature.

  • INACTIVE INGREDIENT

    Inactive ingredient: Resin

  • ASK DOCTOR


    Stop use and ask a doctor if:
    ■ Condition worsens
    ■ Symptom clear up and occur again within a few days.
    ■ Symptom persist for more than 7 days.
    ■ Nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
    ■ Excessive irritation of the skin develops
    ■ When using for pain of arthritis:
    ■ In conditions affecting children under 12 years of age
    ■ If red nose is present
    ■ If pain persists for more than 10 days 

  • KEEP OUT OF REACH OF CHILDREN

    Keep out reach of children to avoid accidental poisoning. If swallowed, get medical help or consult a poison control center right away.

  • DO NOT USE

    Do not use:
    ■ On wounds
    ■ On infected or damaged skin
    When using this product:
    ■ Avoid contact with eyes or mucous membranes.
    ■ Do not bandage tightly.

    PURPOSE

    EXTERNAL ANALGESIC

  • PRINCIPAL DISPLAY PANEL

    MandAHerbalPlaster

  • INGREDIENTS AND APPEARANCE
    PLASTER  MANDAHERBALPLASTER
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14319-3118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.2 g  in 30 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE1.5 g  in 30 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.24 g  in 30 g
    MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L) MYRRH.90 g  in 30 g
    SESAME OIL (UNII: QX10HYY4QV) (SESAME OIL - UNII:QX10HYY4QV) SESAME OIL3.00 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    PINUS TABULIFORMIS BARK (UNII: 3G75L8C3RU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14319-3118-56 in 1 POUCH
    130 g in 1 PATCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/25/2005
    Labeler - Dah Wei Chem & Pharm Co., Ltd. (656347770)