Label: SHEXIANG ZHUANGGU GAO- camphor, menthol, methyl salicylate 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 April 2, 2019

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  • Active Ingredients

    Camphor 1.91%   External Analgesic

    Menthol 2.54%:   External Analgesic

    Methyl Salicylate 1.62%:   External Analgesic

  • Uses

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

    Simple backache
    Arthritis
    Strains
    Bruises
    Sprains

  • Do Not Use

    On wounds
    On irritated or damaged skin
    If the appearance of this product has changed
    In excess of 12 hours
    If known sensitivity this product
    Otherwise than as Directed

  • Ask a doctor or pharmacist before use if you are:

    Pregnant, or taking other medications

  • 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

    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

    If swallowed get medical help or contact a Poision 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 12 hours

    Children 2 to 12 years of age and adults with compromised health: use only the guidance of a doctor

    Children under 2 years of age: do not use

  • Allergy Alert:

    This product contains natural rubber latex which may cause allergic reactions

    Other Information:

    Keep container tightly closed

    Store below 20C in a dry area.

  • Inactive Ingredients

    STAR ANISE
    ANGELICA DAHURICA ROOT 
    ATRACTYLODES LANCEA ROOT 
    ANGELICA SINENSIS ROOT 
    GINGER 
    CYNANCHUM PANICULATUM WHOLE 
    KAEMPFERIA GALANGA ROOT 
    GERANIUM WILFORDII WHOLE 
    CYATHULA OFFICINALIS ROOT 
    MUSCONE 
    CHONDROITIN SULFATE (PORCINE) 
    BORNEOL 
    NATURAL LATEX RUBBER 
    ROSIN 
    ZINC OXIDE 
    PETROLATUM
    LANOLIN 
    PARAFFIN

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    SHEXIANG ZHUANGGU GAO 
    camphor, menthol, methyl salicylate plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51367-033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)30.53 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40.71 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE25.95 mg
    Inactive Ingredients
    Ingredient NameStrength
    STAR ANISE (UNII: XKC1657P78)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    GINGER (UNII: C5529G5JPQ)  
    CYNANCHUM PANICULATUM WHOLE (UNII: T14ONG8D7H)  
    KAEMPFERIA GALANGA ROOT (UNII: 7B7U9D12AI)  
    GERANIUM WILFORDII WHOLE (UNII: QXI974Y72W)  
    CYATHULA OFFICINALIS ROOT (UNII: BRM37UP34O)  
    MUSCONE (UNII: UPS3C6CV36)  
    CHONDROITIN SULFATE (PORCINE) (UNII: V5E8ELO4W9)  
    BORNEOL (UNII: M89NIB437X)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    ROSIN (UNII: 88S87KL877)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51367-033-1010 in 1 BOX; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)04/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/15/2019
    Labeler - International Nature Nutraceuticals (006106879)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inner Mongolia Horqin Pharmaceutical Co.,Ltd548635483manufacture(51367-033)
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