HYSAN HUA TUO MEDICATED PLASTER (MENTHOL, METHYL SALICYLATE) PLASTER [HYSAN PHARMACEUTICAL CO LTD]

HYSAN HUA TUO MEDICATED PLASTER (MENTHOL, METHYL SALICYLATE) PLASTER [HYSAN PHARMACEUTICAL CO LTD]
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NDC 63255-001-01
Set ID e158547a-11d2-407e-98b7-a4c15bed8dbc
Category HUMAN OTC DRUG LABEL
Packager HYSAN PHARMACEUTICAL CO LTD
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredients

    Menthol 5%

    Methyl Salicylate 1%

  • PURPOSE

    Purpose

    External Analgesic

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves minor aches and pains of muscles, stiffness around the neck and shoulders and joint pains due to:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • WARNINGS

    Warnings

    • external use only
    • use only as directed
  • DO NOT USE

    Do Not use

    • on opened wounds
    • on damaged skin
    • eczema
    • hairy surface of skin
  • ASK DOCTOR

    Ask a doctor or pharmacist before use if you are

    • prone to allergic reactions from medicine and/or cosmetic
    • children under 12 years of age, and if you are pregnant or nursing a baby
  • WHEN USING

    When using this product

    • avoid contact with the eyes or mucous membranes
    • highly adhesive plaster may hurt skin upon removal
  • STOP USE

    Stop use and ask a doctor if

    • a rash or irritation develops
    • condition worsens
    • symptoms persist for more than 7 days or clears up and occur again within a few days
  • 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 12 years and older, clean and dry the affected area, and apply to affected area not more than 3 to 4 times daily
    • if you have sensitive skin, try a small piece of the plaster on the arm for 60 minutes before first use. If rash, redness or itching results, discontinue use and consult a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients

    Sesame Oil, Yellow Wax, Myrrh, Frankincense

  • PRINCIPAL DISPLAY PANEL

    Hysan_HuaTou_Plaster

  • INGREDIENTS AND APPEARANCE
    HYSAN HUA TUO MEDICATED 
    menthol, methyl salicylate plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63255-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE1 g
    Inactive Ingredients
    Ingredient NameStrength
    SESAME OIL (UNII: QX10HYY4QV)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MYRRH (UNII: JC71GJ1F3L)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63255-001-015 in 1 BOX; Type 0: Not a Combination Product12/04/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/04/2013
    Labeler - HYSAN PHARMACEUTICAL CO LTD (666427133)
    Establishment
    NameAddressID/FEIBusiness Operations
    HYSAN PHARMACEUTICAL CO LTD666427133manufacture(63255-001)

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