Label: ZHUANG GU FENG SHI PAIN RELIEVING PLASTER- methyl salicylate, camphor, menthol plaster

  • NDC Code(s): 51367-022-08
  • 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 July 31, 2017

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  • Active Ingredients:

    Methyl Salicylate: 12%...External Analgesic

    Camphor: 3.8%....External Analgesic

    Menthol: 2.6%....Extermal Analgesic

  • Uses:

    For the temporary relief of minor aches and pains of muscles and joints due to: simple backache, arthritis, strains, bruises, strains

  • Warnings:

    For external use only

  • When Using this product:

    Avoid contact with the eyes. Do not apply to wounds or damaged skin. Do not bandage tightly.

  • Ask a doctor or pharmacist before use if:

    You are allergic to salicylates or asprin.

  • 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.

  • Keep out of reach of children

    In case 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 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.

  • Storage

    Store at 15°C to 30°C (59°F to 86°F)

    Keep away from heat

  • Inactive Ingredients

    Kaemferia galanga root, ginger, angelica dahurica root, atractylodes lancea root, angelica sinensis root, anise, ephedra sinica stem, natural latex rubber

  • Package

    package
  • INGREDIENTS AND APPEARANCE
    ZHUANG GU FENG SHI PAIN RELIEVING PLASTER 
    methyl salicylate, camphor, menthol plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51367-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE118.8 mg
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)116 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL116 mg
    Inactive Ingredients
    Ingredient NameStrength
    ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O)  
    KAEMPFERIA GALANGA ROOT (UNII: 7B7U9D12AI)  
    GINGER (UNII: C5529G5JPQ)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    ANISE (UNII: 21C2F5E8RE)  
    EPHEDRA SINICA STEM (UNII: 55L3XLO37E)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51367-022-088 in 1 PACKAGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)07/16/1977
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/16/1977
    Labeler - International Nature Nutraceuticals (006106879)
    Establishment
    NameAddressID/FEIBusiness Operations
    Huangshi Hygienic Material Medicine Co., Ltd527157596manufacture(51367-022)
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