Label: YAO SHEN GAO 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 August 1, 2012

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  • Active Ingreidents

    Camphor- 43.76 mg

    Menthol- 37.02 mg

    Methyl Salicylate- 72.39 mg

  • Uses

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

    Simple backache

    Arthritis

    Muscle aches

    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 sensitive to this product

  • Ask a Doctor or Pharmacist before use if you are

    Pregnant

    Taking other medications

  • When Using this Product

    Acoid contact with eyes or mucous membranes

    Do not bandage tightly

    Supervise use by children

    Use caution if prone to allergic reactions

  • Stop Use and Ask a Doctor if

    Condition worsens

    Sumptoms persit 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

  • 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 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
    Store in a dry place

  • Inactive Ingredients

    Chinese Star Anise, Prepared Rehmannia Root, Malaytea Scurfpea Fruit, Epimedium Herb, Common Cnidium Fruit, Twotothed Achranthes Root, Himalayan Teasel Root, Liquorice Root, Eucommia Bark, Dodder Seed, Barbary Wolfberry Fruit, Boswellin, Gum Myrrh, Clore, Songaria Cynomorium Herb, Cassia Bark Oil, Beautiful Sweetgum Resin

    Excipients:

    Petrolatum album, Lanolin, Calcium Carbonate

  • Packaging

    package

  • INGREDIENTS AND APPEARANCE
    YAO SHEN GAO PAIN RELIEVING PLASTER 
    camphor, menthol, methyl salicylate plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51367-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)43.76 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL37.02 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID72.39 mg
    Inactive Ingredients
    Ingredient NameStrength
    STAR ANISE FRUIT (UNII: CK15HA8438)  
    REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
    CULLEN CORYLIFOLIUM FRUIT (UNII: 78AD6Z52S6)  
    EPIMEDIUM GRANDIFLORUM WHOLE (UNII: S57NI79KGP)  
    CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)  
    ACHYRANTHES BIDENTATA ROOT (UNII: 5QIU26R6P1)  
    DIPSACUS ASPER ROOT (UNII: LB1GQP4253)  
    LICORICE (UNII: 61ZBX54883)  
    EUCOMMIA ULMOIDES BARK (UNII: L878N1L0AR)  
    CUSCUTA CHINENSIS SEED (UNII: 77SZY178UD)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    PLANTAGO MAJOR SEED (UNII: YP0NFQ834U)  
    FENNEL (UNII: 557II4LLC3)  
    ACONITUM CARMICHAELII ROOT (UNII: XJ28061U1S)  
    SCHISANDRA CHINENSIS FRUIT (UNII: ABS794681C)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    MYRRH (UNII: JC71GJ1F3L)  
    SYZYGIUM AROMATICUM WHOLE (UNII: EY9MMA0P6Y)  
    CHINESE CINNAMON OIL (UNII: A4WO0626T5)  
    LIQUIDAMBAR STYRACIFLUA RESIN (UNII: P41GWD11CX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51367-004-088 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/29/1985
    Labeler - International Nature Nutraceuticals (006106879)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Dezhong Pharmaceutical Co., Ltd529754442manufacture(51367-004)
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