E MEI SHAN MEDICATED (CAMPHOR, MENTHOL) PLASTER [ZHEJIANG DINGTAI PHARMACEUTICAL CO., LTD]

E MEI SHAN MEDICATED (CAMPHOR, MENTHOL) PLASTER [ZHEJIANG DINGTAI PHARMACEUTICAL CO., LTD]
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NDC 69070-300-01
Set ID bda1e7c1-42df-4126-a512-80f843b07fd0
Category HUMAN OTC DRUG LABEL
Packager Zhejiang Dingtai Pharmaceutical Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active Ingredients
    Camphor 3.1%
    Menthol 2.6%

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  • PURPOSE

    Purpose
    External Analgesic
    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

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

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  • DO NOT USE

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

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  • ASK DOCTOR/PHARMACIST

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

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  • 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

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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
    ■ 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

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  • 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.

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  • 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

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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
    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

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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

    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

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  • INGREDIENTS AND APPEARANCE
    E MEI SHAN MEDICATED 
    camphor, menthol plaster
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69070-300
    Route of Administration TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 31 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 26 mg
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69070-300-01 1 in 1 BOX 09/17/2018
    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 09/17/2018
    Labeler - Zhejiang Dingtai Pharmaceutical Co., Ltd (420598724)
    Establishment
    Name Address ID/FEI Business Operations
    Zhejiang Dingtai Pharmaceutical Co., Ltd 420598724 manufacture(69070-300)
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