Label: SHEXIANG ZHUANGGUGAO (methyl salicylate and camphor- synthetic and menthol plaster

  • NDC Code(s): 51367-034-02, 51367-034-10
  • Packager: International Nature Nutraceuticals
  • 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 26, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients, quantities and it's purpose : 

    Methyl Salicylate
    Camphor
    Methnol

  • Uses: 

    For the temporary relief of minor aches

    and pains of muscles and joints due to :

    Simple backache.    Arthritis. Strains.

    Bruises. Sprains. 

  • Warnings:

    When using this product. Avoid contact with the

    eyes. Do not apply to wounds or damges skin.

    Do not bandage tightly. 

  • Warnings: 

    Ask a doctor or pharmacist before use if you are

    allergic to salicylates or aspirin.

  • Warnings: 

    Stop use and ask a doctor if condition worsens,

    or if symptoms persist for more than 7 days or 

    clear up and occur again within a few days.

        If pregnant or breast-feeding, ask a health

    professional before use. 

  • Inactive Ingredients:

    If you have any questions about this product, please

    use the following telephone numbers to contact us:

    011-86-714-6582928

  • Keep out of reach of children

    In case swallowed, get medical help or contact

    a Poison Control Center right away.

  • Warnings:

    For External Use Only.  

  • Directions:

    adults and children 12 years of age and older

    apply one or two plasters to affected area

    once a day, remove after 8 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. 

  • Uses: 

    For the temporary relief of minor aches 

    and pains of muscles and joints due to :

    Simple backache. Arthritis. Strains.

    Bruises. Sprains.

  • Inactive Ingredients: 

    kaempferia Galanga Root.Ginger. Angelica dahurica
    root. Atractylodes lancea root. Angelica sinensis root.
    Anise. Ephedra Sinica Stem. Natural latex rubber.
    Lanolin. Petrolatum . Aconitum Kusnezoffii Root .
    Aconitum Carmichaelii Root. Artificial moschus .
    Borneol.Chondroitin sulfate (porcine), Chondroitin
    sulfate (chicken) . Zinc oxide, Rosin 

  • Storage: 

    store at 15 C to 30 C (59 F to 86 F)

    keep away from heat 

  • Shexiang ZhuanggugaoPain Relieving Plaster

    package.jpgpackage.jpg

  • INGREDIENTS AND APPEARANCE
    SHEXIANG ZHUANGGUGAO 
    methyl salicylate and camphor (synthetic) and menthol plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51367-034
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic)21.78 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE29 mg
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM18.67 mg
    Inactive Ingredients
    Ingredient NameStrength
    KAEMPFERIA GALANGA ROOT (UNII: 7B7U9D12AI)  
    GINGER (UNII: C5529G5JPQ)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    ANISE (UNII: 21C2F5E8RE)  
    EPHEDRA SINICA STEM (UNII: 55L3XLO37E)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ROSIN (UNII: 88S87KL877)  
    ACONITUM KUSNEZOFFII ROOT (UNII: 3L29I4K8KX)  
    ACONITUM CARMICHAELII ROOT (UNII: XJ28061U1S)  
    MOSCHUS MOSCHIFERUS WHOLE (UNII: W5Y0EFG88O)  
    BORNEOL (UNII: M89NIB437X)  
    CHONDROITIN SULFATE (PORCINE) (UNII: V5E8ELO4W9)  
    CHONDROITIN SULFATE (CHICKEN) (UNII: 7VZ9466BAB)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51367-034-101 in 1 BOX01/01/2021
    110 in 1 PACKET; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:51367-034-025 in 1 BOX01/01/2021
    22 in 1 PACKET; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34801/01/2021
    Labeler - International Nature Nutraceuticals (006106879)
    Establishment
    NameAddressID/FEIBusiness Operations
    Huangshi Hygienic Material Medicine Co. Ltd527157596MANUFACTURE(51367-034)
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