Label: ZHUANG GU SHE XIANG ZHI TONG GAO- camphor, menthol plaster

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 27, 2014

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  • ACTIVE INGREDIENTS

    Camphor  3.0%

    Menthol 2.9%

  • PURPOSE

    Camphor   External Analgesic

    Menthol    External Analgesic

  • USES

    For the temporary relief of minor aches and pains of muscles and joints due to:

    simple backache

    arthritis

    strains

    bruises

    sprains

  • Warning

    For External use only.

    Allergy alert: This product contains natural rubber latex which may cause allergic reactions.

  • Do not use

    on wounds

    on irritated or damaged skin

    if the appearance of this product has changed

    in excess of 12 hours

    if you have known hypersensitives to this product

    otherwise than as directed

  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

    pregnant

    taking other medications

  • WHEN USING THIS PRODUCT

    avoid contact with the eye or mucous membrances

    do not bandage tightly

    supervise use by children

    use caution if prone to allergic reactions

  • 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 irritaion of the skin develops

    when using for pain of athritis

    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.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    Adults and children 12 years of age and older: Apply one or two plasters to affected area once a day. Remove after 12 hours.
    Children 2 to 12 years of age and adults with compromised health: Use only under the guidance of a doctor.
    Children under 2 years of age: Do not use, consult a doctor.
    Refer to the above warnings: use otherwise than as directed may be dangerous.

  • Other Information

    Keep container tightly closed.

    Store below 20 degree centigrade (68 E F) in a dry area.

  • Inactive Ingredients

    BOSWELLIA SACRA BARK, COMMIPHORA MYRRHA TOP, CLOVE, CINNAMOMUM AROMATICUM WHOLE, SCHIZONEPETA TENUIFOLIA WHOLE, SAPOSHNIKOVIA DIVARICATA ROOT, GERANIUM WILFORDII TOP, PERIPLOCA SEPIUM ROOT BARK, DRYNARIA FORTUNEI ROOT, ANGELICA DAHURICA ROOT, GINGER, BORNEOL, BELLADONNA LEAF, NATURAL LATEX RUBBER, ROSIN, ZINC OXIDE, LANOLIN, PARAFFIN, DIMETHYL SULFOXIDE, ANTIOXIDANT 119, METHYL SALICYLATE, MUSK KETONE

  • Questions or Comments?

    E-mail: info@bjwellspring.com

  • Drug Facts

    image description

  • INGREDIENTS AND APPEARANCE
    ZHUANG GU SHE XIANG ZHI TONG GAO 
    camphor, menthol plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42217-203
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3.0 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BOSWELLIA SACRA BARK (UNII: 1UK28DX728)  
    COMMIPHORA MYRRHA TOP (UNII: N534J96ODY)  
    CLOVE (UNII: K48IKT5321)  
    CINNAMOMUM AROMATICUM WHOLE (UNII: 9BPF21T8ZR)  
    SCHIZONEPETA TENUIFOLIA WHOLE (UNII: C1107616TR)  
    SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)  
    GERANIUM WILFORDII TOP (UNII: 771B1S9W3R)  
    PERIPLOCA SEPIUM ROOT BARK (UNII: 638OW484M3)  
    DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    GINGER (UNII: C5529G5JPQ)  
    BORNEOL (UNII: M89NIB437X)  
    BELLADONNA LEAF (UNII: 6GZW20TIOI)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    ROSIN (UNII: 88S87KL877)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    ANTIOXIDANT 119 (UNII: UBL01213LI)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    MUSK KETONE (UNII: 483V3E1L6J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42217-203-1010 in 1 BOX
    11 g in 1 PATCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/02/2010
    Labeler - Henan Lingrui Pharmaceutical Co.; Ltd (530021062)
    Registrant - Henan Lingrui Pharmaceutical Co.; Ltd (530021062)
    Establishment
    NameAddressID/FEIBusiness Operations
    Henan Lingrui Pharmaceutical Co.; Ltd530021062manufacture(42217-203)
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