Label: LUNG CHOY SHUNG PAIN RELIEF LIQUID- menthol and camphor liniment

  • 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 March 26, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient
    Menthol 2.8%
    Camphor 2.8%

  • 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

    Flammable: Keep away from fire or flame.

  • DO NOT USE

    Do not use
    on irritated or damaged skin
    on wounds
    if you are allergic to any ingredient in this product

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you have
    any concerns about using this product

  • WHEN USING

    When using this product
    avoid contact with the eyes or mucous membranes
do not bandage tightly
    
do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)

  • 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

    you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)

    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. 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 not more than 3 to 4 times daily.
    children under 2 years of age: consult your physician

  • STORAGE AND HANDLING

    Other information
    cap bottle tightly
    store at room temperature, away from heat

  • INACTIVE INGREDIENT

    Inactive ingredients
    Alcohol, alisma plantago-aquatica subsp. orientale root , angelica dahurica root, angelica sinensis root, atractylodes lancea root, atractylodes macrocephala root, cinnamomum cassia twig, citrus aurantium fruit, cullen corylifolium fruit, cuscuta chinensis seed, cyperus rotundus tuber, dioscorea villosa tuber, erycibe obtusifolia stem, fennel seed, frankincense, gleditsia sinensis fruit, ligusticum sinense subsp. chuanxiong root, myrrh, notopterygium franchetii root, paeonia x suffruticosa root bark, panax notoginseng root, polygonatum sibiricum root, polysorbate 80, prunus armeniaca seed, purified water, and tangerine peel.

  • 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

    Lung Choy Shung Pain Relief Liquid
    External Analgesic
    NDC 55614-600-01
    Menthol and Camphor
    6.76 fl oz (200 mL)

    Box3.jpg

  • INGREDIENTS AND APPEARANCE
    LUNG CHOY SHUNG PAIN RELIEF LIQUID 
    menthol and camphor liniment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55614-600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.8 g  in 100 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)2.8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ALISMA PLANTAGO-AQUATICA SUBSP. ORIENTALE ROOT (UNII: 555C7I140L)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O)  
    ATRACTYLODES MACROCEPHALA ROOT (UNII: 08T3N29QJB)  
    CINNAMOMUM CASSIA TWIG (UNII: 4UD6VQR2UP)  
    CITRUS AURANTIUM FRUIT (UNII: DQD16J2B5O)  
    CULLEN CORYLIFOLIUM FRUIT (UNII: 78AD6Z52S6)  
    CUSCUTA CHINENSIS SEED (UNII: 77SZY178UD)  
    CYPERUS ROTUNDUS TUBER (UNII: 4B51SRR959)  
    DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)  
    ERYCIBE OBTUSIFOLIA STEM (UNII: V1G1S38CQI)  
    FENNEL SEED (UNII: G3QC02NIE6)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    GLEDITSIA SINENSIS FRUIT (UNII: A6W0J6UO7Q)  
    LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97)  
    MYRRH (UNII: JC71GJ1F3L)  
    NOTOPTERYGIUM FRANCHETII ROOT (UNII: KRT28P6ITK)  
    PAEONIA X SUFFRUTICOSA ROOT BARK (UNII: BUG255FE7X)  
    PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)  
    POLYGONATUM SIBIRICUM ROOT (UNII: O6N69G5Q18)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PRUNUS ARMENIACA SEED (UNII: 75356789IW)  
    WATER (UNII: 059QF0KO0R)  
    TANGERINE PEEL (UNII: JU3D414057)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55614-600-01200 mL in 1 BOTTLE; Type 0: Not a Combination Product11/25/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/25/2019
    Labeler - MADISON ONE ACME INC (096196758)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(55614-600)