Label: HUO PAO TIEH TA FENG SHIN KAO- l-menthol, camphor plaster

  • Category: HUMAN OTC DRUG LABEL

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: 

    each 5 g patch contains

    L-Menthol      200 mg

    Camphor        40 mg

  • Purpose:

    External analgesic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out reach of children to avoid accidental poisoning. If swallowed, get medical help or consult a poison control center right away.

  • Uses:

    for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis strains, bruises and sprains.

  • Warnings:

    For external use only

    Do not use:
    ■ On wounds
    ■ On infected or damaged skin

    When using this product:

    ■ Avoid contact with eyes or mucous membranes.
    ■ Do not bandage tightly.

    Stop use and ask a doctor if:

    ■ Condition worsens
    ■ Symptom clear up and occur again within a few days.
    ■ Symptom persist for more than 7 days.
    ■ Nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
    ■ Excessive irritation of the skin develops

    ■ When using for pain of arthritis:
       ■ In conditions affecting children under 12 years of age
       ■ If redness is present
       ■ If pain persists for more than 10 days

  • Dirctions:

    • Adult & children 12 years of age and older
    • Remove the clear film backing and apply to the sore area of skin.
    • Use not more than three times daily
    • Bandage will remain effective after 24 hours and will be even more effective when using after bath.
    • Do not apply to extremely hairy skin
    • Highly adhesive bandage may hurt skin upon removal
    • For children under 12 years of age, do not use, consult a doctor
  • Other information:

    • Keep container tightly closed, once opened, fold the opening and keep pressed closed with a clip
    • Store at room temperature
  • Inactive Ingredients:

    Sesame Oil

    Rehmania                      Rehmannia glutinosa

    Fragrant Angelica           Angelica dahurica

    Dong quai                     Angelica sinensis

    Chinese peony               Poeonia lactiflora

    Notopterygium               Notopterygium incisum

    Bletilla                          Bletilla striata

    Lindera                         Lindera aggregata

    Chinese licorice              Glycyrrhiza uralensis

    Pubescent angelica         Angelica pubescens

    Scrophularia                  Scrophularia ningpoensis

    Chinese rhubarb             Reheum palmatum

    Cassia                          Cinnamomum aromaticum

    Myrrha                         Commiphora myrrha

    Chinese mint                 Mentha canadensis

  • U.S. Distributer:

    EAST COAST
    FARCEDES TRADING INC.
    295 KENT AVE, BROOKLYN
    N,Y.,11211

    WEST COAST
    KWOK HONG CHINESE HERBS, INC
    3309 BALBOA STREET,
    SAN FRANCISCO,CA 94121

  • Packaging

    PLaster label

  • INGREDIENTS AND APPEARANCE
    HUO PAO TIEH TA FENG SHIN KAO 
    l-menthol, camphor plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62209-9266
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL200 mg  in 5 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)40 mg  in 5 g
    Inactive Ingredients
    Ingredient NameStrength
    SESAME OIL (UNII: QX10HYY4QV)  
    MYRRH (UNII: JC71GJ1F3L)  
    REHMANNIA GLUTINOSA WHOLE (UNII: 37S3F886KQ)  
    ANGELICA DAHURICA WHOLE (UNII: 667W6C5J4P)  
    ANGELICA SINENSIS WHOLE (UNII: 697D19QDBN)  
    PAEONIA LACTIFLORA WHOLE (UNII: N44H57P7WG)  
    NOTOPTERYGIUM INCISUM WHOLE (UNII: N8519Y5E6X)  
    BLETILLA STRIATA WHOLE (UNII: WV2BSG60EW)  
    LINDERA AGGREGATA WHOLE (UNII: 3ZU402829L)  
    GLYCYRRHIZA URALENSIS (UNII: 42B5YD8F0K)  
    ANGELICA PUBESCENS WHOLE (UNII: SV5CN7O3MB)  
    SCROPHULARIA NINGPOENSIS WHOLE (UNII: 2FW4P6X3W8)  
    RHEUM PALMATUM WHOLE (UNII: 75P857ARCY)  
    CINNAMOMUM AROMATICUM WHOLE (UNII: 9BPF21T8ZR)  
    MENTHA ARVENSIS WHOLE (UNII: 46477RRB3O)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62209-9266-56 in 1 BAG
    15 g in 1 PATCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/06/2013
    Labeler - Dah Wei Biochemical Pharmaceutic International Ltd. (657087313)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dah Wei Biochemical Pharmaceutic International Ltd.657087313manufacture(62209-9266)