Label: SHANGHAI SHANG SHI ZHI TONG GAO PAIN RELIEVING- camphor, menthol, methyl salicylate patch

  • 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 November 13, 2019

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  • ACTIVE INGREDIENT

    Active ingredients
    Camphor 10%
    Menthol 10.28%
    Methyl salicylate 15.43%

  • PURPOSE

    Purpose
    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

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

  • DO NOT USE

    Do not use
    on wounds
    on irritated or damaged skin
    if pregnant
    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: clean and dry the skin and apply the patch to the affected area not than 3 to 4 times daily. Each patch is effective for 2-3 days.
    children under 3 years of age: consult your physician.
    refer to the above warnings; use otherwise than as directed may be dangerous.

  • STORAGE AND HANDLING

    Other information
    for unused patches remaining in the pouch, re-seal securely
    store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredientsCinnamon, clove extract, drynaria root and stem, fang feng root, fragrant angelica root, frankincense resin, geranium (Geranium wilfordii Maxim) stem, leaf, and fruit, glycerol ester of rosin gum, gotu kola herb, greater galangal root and stem, kaolin, lanolin, lithopone (mixture of barium sulfate, zinc sulfide, and trace zinc oxide), mineral oil, myrrh, oriental sweet gum (Liquidambar orientalis Mill.) resin, paraffin, periploca sepium (Periploca sepium Bunge) bark, petrolatum, schizonepeta [Schizonepeta tenuifolia (Benth.) Briq.] stem and leaf, on a rubberized fabric backing covered with a protective paper sheet.

  • QUESTIONS

    Questions or comments? (888) 221-3496 M-F 9 am to 5 pm
    you may also report serious side effects to thi phone number

  • PRINCIPAL DISPLAY PANEL

    SHANGHAI SHANG SHI ZHI TONG GAO

    Pain Relieving Patch

    External Analgesic

    NDC 22742-003-01

    6 Patches in 3 Pouches Each Patch 2.75 in x 3.94 in (7 cm x 10 cm)

    IMAGE OF CARTON

  • INGREDIENTS AND APPEARANCE
    SHANGHAI SHANG SHI ZHI TONG GAO PAIN RELIEVING 
    camphor, menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22742-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)10 
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10.28 
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15.43 
    Inactive Ingredients
    Ingredient NameStrength
    CINNAMON (UNII: 5S29HWU6QB)  
    CLOVE (UNII: K48IKT5321)  
    DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)  
    SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    GERANIUM WILFORDII WHOLE (UNII: QXI974Y72W)  
    ROSIN PARTIALLY DIMERIZED GLYCEROL ESTER (UNII: BY866DXY67)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    ALPINIA GALANGA WHOLE (UNII: 3S1W839C0O)  
    KAOLIN (UNII: 24H4NWX5CO)  
    LANOLIN (UNII: 7EV65EAW6H)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ZINC SULFIDE (UNII: KPS085631O)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    MYRRH (UNII: JC71GJ1F3L)  
    LIQUIDAMBAR ORIENTALIS WHOLE (UNII: 759QNU787E)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PERIPLOCA SEPIUM ROOT BARK (UNII: 638OW484M3)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SCHIZONEPETA TENUIFOLIA WHOLE (UNII: C1107616TR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22742-003-013 in 1 BOX03/09/2009
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/09/2009
    Labeler - SHANGHAI LEI YUN SHANG PHARMACEUTICAL CO LTD (420978637)
    Registrant - SHANGHAI LEI YUN SHANG PHARMACEUTICAL CO LTD (420978637)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHANGHAI LEI YUN SHANG PHARMACEUTICAL CO LTD420978637manufacture(22742-003)
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