Label: E MEI SHAN MEDICATED- camphor, menthol, methyl salicylate plaster

  • 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 August 11, 2017

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  • ACTIVE INGREDIENT

    Active Ingredients
    Camphor 3.1%
    Menthol 2.6%
    Methyl Salicylate 10.1%

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

  • DO NOT USE

    Do not use
    ■ on irritated or damaged skin ■ on wounds ■ otherwise than as directed

  • WHEN USING

    When using this product
    ■ avoid contact with the eyes or mucous membranes
    ■ do not bandage tightly
    ■ 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
    ■ 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 to avoid accidental poisoning.
    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    ■ adults and children 3 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 3 years of age: consult your physician
    ■ refer to the above warnings; use otherwise than as directed may be dangerous

  • 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
    Dong quai root, fragrant angelica root, ginger, lanolin, mineral oil, natural latex rubber, petrolatum, rosin, zinc oxide, star anise fruit, and antioxidant 1010.

  • 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

    Principal Display Panel
    EXTERNAL ANALGESIC
    NDC 54494-001-01
    E MEI SHAN MEDICATED PLASTER
    ■ Simple backache ■ Arthritis ■ Strains ■ Bruises ■ Sprains
    5 PLASTERS
    Each plaster 7 x 10 cm (2.76 x 3.94 Inches)
    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    E MEI SHAN MEDICATED 
    camphor, menthol, methyl salicylate plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54494-001
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)36 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE119 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    GINGER (UNII: C5529G5JPQ)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    ROSIN (UNII: 88S87KL877)  
    STAR ANISE FRUIT (UNII: CK15HA8438)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54494-001-011 in 1 BOX02/19/2013
    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 finalpart34802/19/2013
    Labeler - SICHUAN EMEISHAN PHARMACEUTICAL CO., LTD. (529114359)
    Registrant - SICHUAN EMEISHAN PHARMACEUTICAL CO., LTD. (529114359)
    Establishment
    NameAddressID/FEIBusiness Operations
    SICHUAN EMEISHAN PHARMACEUTICAL CO., LTD.529114359manufacture(54494-001)
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