Label: DIE DA WAN HUA PAIN RELIEVING- turpentine oil

  • NDC Code(s): 61821-001-01
  • Packager: GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL CO., LTD
  • 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 November 13, 2019

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  • ACTIVE INGREDIENT

    Active ingredient
    Turpentine oil 6%

  • PURPOSE

    Purpose
    External analgesic

  • INDICATIONS & USAGE

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

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • WARNINGS

    Warnings
    For external use only

  • DO NOT USE

    Do not use


    • on wounds
    • on irritated or damaged skin
  • WHEN USING

    When using this product

    avoid contact with the eyes or mucous membranes
    
do not bandage tightly

  • STOP USE

    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

    • nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
    • 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. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 2 years of age and older: Apply a few drops to affected area and rub gently. Do not use more than 3 to 4 times a day.
    • Children under 2 years of age: Do not use, consult a doctor.
  • STORAGE AND HANDLING

    Other information

    • keep in a tightly closed container
    • 
store in a cool dry place away from sunlight
  • INACTIVE INGREDIENT

    Inactive ingredients
    Camellia (Tsubaki oil) oil, cleistocalyx (Cleistocalyx operculatus) flower, dock (yang ti huang) root, dragon’s blood (xue jie) resin, drynaria (gu sui bu) rhizome, kudzu (ge hua) flower, lacca secretion (zi cao rong), lineate supplejack (Berchemia lineata) root, ragwort (Senecio palmatus), safflower (hong hua) flower, safflower (hong hua) oil, and winter sweet.

  • QUESTIONS

    Questions or comments?(888) 221-3496 M-F 9 am to 5 pm

  • PRINCIPAL DISPLAY PANEL

    DIE DA WAN HUA PAIN RELIEVING OIL
    External Analgesic
    NDC 61821-001-01
    1.69 fl oz (50 mL)
    IMAGE OF CARTON

  • INGREDIENTS AND APPEARANCE
    DIE DA WAN HUA PAIN RELIEVING 
    turpentine oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61821-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TURPENTINE (UNII: XJ6RUH0O4G) (TURPENTINE - UNII:XJ6RUH0O4G) TURPENTINE6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAMELLIA OIL (UNII: T1PE06G0VE)  
    SYZYGIUM NERVOSUM FLOWER BUD (UNII: 7FA55IY5H8)  
    RUMEX JAPONICUS ROOT (UNII: Q0N15YJ5EJ)  
    DRAGON'S BLOOD (UNII: M3YJ2C28IC)  
    DRYNARIA FORTUNEI WHOLE (UNII: TL552SP1Z7)  
    PUERARIA MONTANA VAR. LOBATA FLOWERING TOP (UNII: HAM6R1WA7O)  
    SHELLAC (UNII: 46N107B71O)  
    BERCHEMIA LINEATA ROOT (UNII: J146XBE5WH)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CHIMONANTHUS PRAECOX WHOLE (UNII: 5Y143KS0YL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61821-001-011 in 1 BOX05/08/2003
    150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/08/2003
    Labeler - GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL CO., LTD (654032218)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL CO., LTD654032218manufacture(61821-001)
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