Label: YULAM DIE DA WAN HUA PAIN RELIEVING- menthol and camphor oil

  • 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 2, 2022

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  • ACTIVE INGREDIENT

    Active ingredient
    Menthol 3%
    Camphor 4%

  • PURPOSE

    Purpose
    External analgesic
    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

  • ADVERSE REACTIONS

    Report any unexpected side effects from the use of this product to the FDA MedWatch Program.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning. 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 to affected area and rub gently. Do not use for more than 4 times a day.
    ■ children under 2 years of age: Do not use, consult a doctor.

  • STORAGE AND HANDLING

    Other information
    ■ keep container tightly closed

    ■ store in a cool dry place away from sunlight

  • INACTIVE INGREDIENT

    Inactive ingredients angelica dahurica (bai zhi) root, angelica pubescens (du huo) root, camellia oil, carthamus tinctorius (hong hua) flower bud, chimonanthus praecox (la mei hua) flower, chrysanthemum indicum (yeh chu hua) flower, curcuma involucrata (tu tian qi) root, cynanchum paniculatum (xu chang pu) root, drynaria fortunei (gu sui bu) root, gardenia jasminoides (zhi zi) fruit, ginger (jiang) root, gleditsia sinensis (da zao jiao) fruit, pueraria montana var. lobata (ge hua) flower top, ligusticum sinense (chuan xiong) root, lindera aggergata (wu yao) root, mentha canadensis (bo he) oil, notopterygium incisum (qiang huo) root, paeonia x suffruticosa (mu dan pi) root bark, rheum palmatum (da huang) root, saposhnikovia divaricata (fang feng) root, shellac, syzygium nervosum flower bud, tangerine (qing pi) unripe peel, tangerine (chen pi) peel, xanthium strumarium (cang er zi) fruit, zanthoxylum nitidum (liang mian zhen) root.

  • QUESTIONS

    Questions or comments? (888) 221-3496 M-F 9 am to 5 pm
    ■ you may also report serious side effects to this phone number

  • PRINCIPAL DISPLAY PANEL

    YULAM DIE DA WAN HUA PAIN RELIEVING OIL

    NDC 55614-740-01

    EXTERNAL ANALGESIC

    1.7 FL OZ (50 ML)

    IMAGE OF BOX

  • INGREDIENTS AND APPEARANCE
    YULAM DIE DA WAN HUA PAIN RELIEVING 
    menthol and camphor oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55614-740
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ)  
    CAMELLIA OIL (UNII: T1PE06G0VE)  
    CARTHAMUS TINCTORIUS FLOWER BUD (UNII: B86IS274O0)  
    CHIMONANTHUS PRAECOX WHOLE (UNII: 5Y143KS0YL)  
    CHRYSANTHEMUM INDICUM FLOWER (UNII: I6OER6U04L)  
    CURCUMA INVOLUCRATA ROOT (UNII: EW5ECF6XAX)  
    CYNANCHUM PANICULATUM ROOT (UNII: CZP7EPR012)  
    DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)  
    GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)  
    GINGER (UNII: C5529G5JPQ)  
    GLEDITSIA SINENSIS FRUIT (UNII: A6W0J6UO7Q)  
    PUERARIA MONTANA VAR. LOBATA FLOWERING TOP (UNII: HAM6R1WA7O)  
    LIGUSTICUM SINENSE ROOT (UNII: 32SLT970XO)  
    LINDERA AGGREGATA ROOT (UNII: 517Q7XRT2T)  
    MENTHA CANADENSIS WHOLE (UNII: J1BO4MHT2L)  
    NOTOPTERYGIUM INCISUM ROOT (UNII: 5Z2WW4J6RI)  
    PAEONIA X SUFFRUTICOSA ROOT BARK (UNII: BUG255FE7X)  
    RHEUM PALMATUM ROOT (UNII: G025DAL7CE)  
    SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)  
    SHELLAC (UNII: 46N107B71O)  
    SYZYGIUM NERVOSUM FLOWER BUD (UNII: 7FA55IY5H8)  
    TANGERINE PEEL, UNRIPE (UNII: B077C3NLJV)  
    TANGERINE PEEL (UNII: JU3D414057)  
    XANTHIUM STRUMARIUM FRUIT (UNII: TN770YC17C)  
    ZANTHOXYLUM NITIDUM ROOT (UNII: L2CQZ81759)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55614-740-011 in 1 BOX11/02/2022
    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 finalpart34811/02/2022
    Labeler - MADISON ONE ACME INC (096196758)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL CO., LTD.654032218manufacture(55614-740)
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