Label: ZHUANGGU SHEXIANG ZHITONGGAO PAIN RELIEVING PLASTER- 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 December 27, 2013

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  • Active Ingredients

    Camphor-3.0%
    Menthol- 2.9%

    Methyl Salicylate- 10.4%

  • Uses

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

    • Simple backache
    • Arthritis
    • Strains
    • Bruises
    • Sprains
  • Warnings:

    For External Use Only

  • 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
  • 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

    Keep Out of Reach of Children

  • 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

  • Storage

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

    Keep away from heat

  • Inactive Ingredients

    Frankincense, Myrrh, Schizonepeta tenuifolia flowering top, Saposhnikovia divaricata root, Chinese Cinnamon, Atropa belladona, natural latex rubber, rosin, aconitum kusnezoffi root, aconitum carmichaelii root, strychons nux-vomica seed, clove, erodium stephanianum top, periploca sepium root bark

  • package

    package

  • INGREDIENTS AND APPEARANCE
    ZHUANGGU SHEXIANG ZHITONGGAO PAIN RELIEVING PLASTER 
    camphor, menthol, methyl salicylate plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51367-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)114.29 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL114.29 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE85.72 
    Inactive Ingredients
    Ingredient NameStrength
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    MYRRH (UNII: JC71GJ1F3L)  
    SCHIZONEPETA TENUIFOLIA FLOWERING TOP (UNII: 2FN3BA1MZE)  
    CHINESE CINNAMON (UNII: WS4CQ062KM)  
    SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)  
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    ROSIN (UNII: 88S87KL877)  
    ACONITUM KUSNEZOFFII ROOT (UNII: 3L29I4K8KX)  
    ACONITUM CARMICHAELII ROOT (UNII: XJ28061U1S)  
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919)  
    CLOVE (UNII: K48IKT5321)  
    ERODIUM STEPHANIANUM TOP (UNII: 5307U0XCAS)  
    PERIPLOCA SEPIUM ROOT BARK (UNII: 638OW484M3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51367-019-1010 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/1991
    Labeler - International Nature Nutraceuticals (006106879)
    Establishment
    NameAddressID/FEIBusiness Operations
    Henan Lingrui Pharmaceutical Co., Ltd530021062manufacture(51367-019)
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