Label: E MEI SHAN MEDICATED- camphor, menthol plaster

  • NDC Code(s): 69070-300-01
  • Packager: Zhejiang Dingtai Pharmaceutical Co., Ltd
  • 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 September 17, 2018

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

  • ACTIVE INGREDIENT

    Active Ingredients
    Camphor 3.1%
    Menthol 2.6%

  • PURPOSE

    Purpose
    External Analgesic
    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

    Allergy alert: This product contains natural rubber latex which may cause allergic reactions

    Report any unexpected side effects from the use of this product to the FDA MedWatch Program

  • DO NOT USE

    Do not use
    ■ on irritated or damaged skin ■ on wounds

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you have
    ■ any concerns about using this product

  • WHEN USING

    When using this product
    ■ avoid contact with the eyes or mucous membranes
    ■ do not bandage tightly
    ■ do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)
    ■ avoid placing on extremely hairy areas of skin to avoid irritation upon removing the plaster

  • 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
    ■ excessive irritation of the skin develops
    ■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
    ■ you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)
    ■ when using for pain of arthritis:
          ■ 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: remove the protective film from the plaster. Apply to affected area not more than 3 to 4 times daily.
    ■ children under 2 years of age: consult your physician

  • STORAGE AND HANDLING

    Other information
    ■ keep plasters tightly closed in the zip-lock pouch
    ■ store at 15º to 30º C (59º to 86º F) in a dry place away from sunlight

  • INACTIVE INGREDIENT

    Inactive ingredients
    Butylated hydroxytoluene, dong quai root, fragrant angelica root, ginger root, lanolin, light mineral oil, natural latex rubber, petrolatum, rosin, star anise fruit, and zinc oxide on a cotton pad

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    E MEI SHAN MEDICATED PLASTER

    NDC 69070-300-01

    Simple backache, Arthritis, Strains, Bruises, Sprains

    5 Plaster
    Each Plaster 7 x 10 cm (2.76 x 3.94 in)
    IMAGE OF CARTON

  • INGREDIENTS AND APPEARANCE
    E MEI SHAN MEDICATED 
    camphor, menthol plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69070-300
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)31 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL26 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    GINGER (UNII: C5529G5JPQ)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ROSIN (UNII: 88S87KL877)  
    STAR ANISE (UNII: XKC1657P78)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69070-300-011 in 1 BOX09/17/2018
    15 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/17/2018
    Labeler - Zhejiang Dingtai Pharmaceutical Co., Ltd (420598724)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(69070-300)