JIN GU WANG (CAMPHOR AND MENTHOL) SPRAY [GUANGXI YULIN PHARMACEUTICAL CO LTD]

JIN GU WANG (CAMPHOR AND MENTHOL) SPRAY [GUANGXI YULIN PHARMACEUTICAL CO LTD]
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NDC 59321-032-01
Set ID 26411ade-7069-4f93-8833-6fb1fadd5198
Category HUMAN OTC DRUG LABEL
Packager GUANGXI YULIN PHARMACEUTICAL CO LTD
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredients
    Camphor 5.5%
    Menthol 5.5%

  • PURPOSE

    Purposes
    External analgesic
    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

  • DO NOT USE

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

  • WHEN USING

    When using this product
    avoid contact with the eyes or mucous membranes
    do not bandage tightly

  • 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: Spray on the affected area not more than 3 to 4 times daily.
    Massage the affected area after spraying.
    Alternatively, the product may be sprayed onto medical cotton and lightly bandaged to the affected part.
    children under 3 years of age: Do not use, consult a doctor
    Refer to the above warnings; use otherwise than as directed may be dangerous.

  • STORAGE AND HANDLING

    Other information
    keep tightly closed
    store at room temperature 15° to 30° C (59° to 86° F)

  • INACTIVE INGREDIENT

    Inactive ingredients
    aralia armata Aralia armata (Wall. Ex G. Don) Seem root and stem,
    cinnamon (Cinnamomum cassia J.Presl.) twig,
    dimethyl sulfoxide,
    gleditsia (Gleditsia sinensis Lam.) fruit,
    methyl salicylate,
    paniculate swallowwort Pycnostelma paniculatum (Bge.) K. Schum herb,
    St. Thomas bean Entada phaseoloides (L.) Merr. root,
    and zedoary rhizome.

  • 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

    JIN GU WANG  EXTERNAL ANALGESIC  NDC 59321-032-01  2.0 fl oz (60mL)IMAGE OF CARTON

  • INGREDIENTS AND APPEARANCE
    JIN GU WANG 
    camphor and menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59321-032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5.5 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CINNAMON (UNII: 5S29HWU6QB)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    GLEDITSIA SINENSIS FRUIT (UNII: A6W0J6UO7Q)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    ENTADA PHASEOLOIDES LEAF (UNII: W20C93AH7K)  
    ZEDOARY (UNII: 123C43G128)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59321-032-0160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/07/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/07/2011
    Labeler - GUANGXI YULIN PHARMACEUTICAL CO LTD (653862581)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGXI YULIN PHARMACEUTICAL CO LTD653862581manufacture(59321-032)

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