Label: ZHONG HUA FENG SHI DIE DA GAO EXTERNAL ANALGESIC PLASTER- menthol, methyl salicylate patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 20, 2023

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  • PURPOSE

    Analgesic

  • Drug Facts

    Active IngredientsPurpose
    Menthol 4%External Analgesic
    Methyl Salicylate 1%External Analgesic

  • Uses

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

  • Warnings

    For external use only

    Do not use

    ● on wounds ● irritated or damaged skin ● sensitive skin
    ● with a heating pad ● if pregnant
    ● with, or as the same time as, other external analgesic products
    ● if allergic to aspirin or salicylates
    ● if allergic to any ingredients of this product

    When using this product

    ● avoid contact with the eyes
    ● do not bandage tightly
    ● do not apply to wounds or damaged skin
    ● do not use more than 3 plasters a day
    ● do not use 1 hour before or after bathing

    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
    ● rashes, itching or redness are present
    ● side effects occur.

    If pregnant, ask a health professional before use.

    Keep out of reach of childrento avoid accidental poisoning.

    In case of overdose, get medical help or contact a Poison Control Center right
    away.

    Do not use otherwise than as directed.

  • Directions

    ● Adults and children 12 years of age and older: clean and dry affected area. Remove plaster from the protective layer, apply to the affected area, rub the area with your hand to secure the patch.
    ● Plaster will remain effective for 8 hours.
    ● Avoid using the same patch on the same area for more than 2 days.
    ● Do not apply to area with excessive hair. Adhesive plaster may hurt skin upon removal.
    ● Wet patch with warm water before removing from skin.
    ● Children under 12 years of age: Do not use or consult a doctor.

  • Other Information

    ●Store unused patch in the pouch
    ●Store at room temperature, 20 to 25°C(68 to 77°F)

  • lnactive ingredients

    Chinese Clematidis Root & Rhizome, Yellow wax, Momordica cochinchinensis seeds, Castor Seeds, Myrrh, Frankincense, Sesame Oil, Resin, FD&C Blue No. 2, FD&C Yellow No. 4, Zinc Oxide

  • Questions or Comments

    Call:1-800-796-1888

  • Package Label

    Label

  • INGREDIENTS AND APPEARANCE
    ZHONG HUA FENG SHI DIE DA GAO EXTERNAL ANALGESIC PLASTER 
    menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82198-0005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.01 g  in 1 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CLEMATIS CHINENSIS ROOT (UNII: 8Z18N528CU)  
    PINUS MASSONIANA RESIN (UNII: 64S07U83T7)  
    YELLOW OB (UNII: QE535CBH7S)  
    RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MOMORDICA COCHINCHINENSIS SEED (UNII: 2T87O1UPVD)  
    SESAME OIL (UNII: QX10HYY4QV)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MYRRH (UNII: JC71GJ1F3L)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    ColorgreenScore    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82198-0005-15 in 1 BAG10/11/2021
    11.7 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)10/11/2021
    Labeler - Big 5 Nutrition LLC (114574559)
    Establishment
    NameAddressID/FEIBusiness Operations
    TAIWAN SHUENN-AN BIOTECHNOLOGY PHARMACEUTICAL CO., LTD.656348265manufacture(82198-0005) , pack(82198-0005) , label(82198-0005)
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