E MEI SHAN MEDICATED (CAMPHOR, MENTHOL, METHYL SALICYLATE) PLASTER [SICHUAN EMEISHAN PHARMACEUTICAL CO., LTD.]

E MEI SHAN MEDICATED (CAMPHOR, MENTHOL, METHYL SALICYLATE) PLASTER [SICHUAN EMEISHAN PHARMACEUTICAL CO., LTD.]
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NDC 54494-001-01
Set ID ece6cd1d-e063-454e-909e-5184796286da
Category HUMAN OTC DRUG LABEL
Packager SICHUAN EMEISHAN PHARMACEUTICAL CO., LTD.
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

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

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  • PURPOSE

    Purpose
    External Analgesic

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  • INDICATIONS & USAGE

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

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  • WARNINGS

    Warnings
    For external use only
    Allergy alert: This product contains natural rubber latex which may cause allergic reactions

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  • DO NOT USE

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

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  • 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

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  • 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

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  • 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.

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  • 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

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  • 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

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  • 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.

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  • 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

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  • 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

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  • INGREDIENTS AND APPEARANCE
    E MEI SHAN MEDICATED 
    camphor, menthol, methyl salicylate plaster
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54494-001
    Route of Administration TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 36 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 30 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 119 mg
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54494-001-01 1 in 1 BOX 02/19/2013
    1 5 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 02/19/2013
    Labeler - SICHUAN EMEISHAN PHARMACEUTICAL CO., LTD. (529114359)
    Registrant - SICHUAN EMEISHAN PHARMACEUTICAL CO., LTD. (529114359)
    Establishment
    Name Address ID/FEI Business Operations
    SICHUAN EMEISHAN PHARMACEUTICAL CO., LTD. 529114359 manufacture(54494-001)
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