Label: WONG LOP KONG MEDICATED- 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 13, 2019

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  • ACTIVE INGREDIENT

    Active ingredients
    Camphor 4%

  • 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, sprai

  • WARNINGS

    Warnings
    For external use only
    Allergy alert: Discontinue if irritation or rash appears. Prolonged or frequent skin contact may cause allergic reactions in some individuals.

  • DO NOT USE

    Do not use
    on wounds, on damaged skin

  • WHEN USING

    When using this product
    avoid contact with the eyes
    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

  • 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 a few drops to the affected area and rub gently not more than 3 to 4 times daily.
    Children under 2 years of age: Do not use, consult a doctor.

  • STORAGE AND HANDLING

    Other information
    keep container tightly closed
    store at 15E to 30 C (59 to 86 F)

  • INACTIVE INGREDIENT

    Inactive ingredients
    Camphor Oil, Dong-Quai root, Dragon’s Blood resin, Eucalyptus Oil, Fragrant Angelica Root, Frankincense gum resin, Field Mint herb, Myrrh gum resin, Oil of Citronella, Peppermint Oil, Pine resin, Red-Rooted Sage root, Safflower flower, Sichuan Lovage rhizome, Tea Oil

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    WONG LOP KONG MEDICATED OIL, External Analgesic, NDC 54188–003-01, 1 fl oz (30 mL)IMAGE OF BOX

  • INGREDIENTS AND APPEARANCE
    WONG LOP KONG MEDICATED 
    camphor oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54188-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    DRAGON'S BLOOD (UNII: M3YJ2C28IC)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    MENTHA ARVENSIS WHOLE (UNII: 46477RRB3O)  
    MYRRH (UNII: JC71GJ1F3L)  
    CITRONELLA OIL (UNII: QYO8Q067D0)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PINUS MASSONIANA RESIN (UNII: 64S07U83T7)  
    SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    LIGUSTICUM SINENSE SUBSP. CHUANXIONG WHOLE (UNII: CAX256379F)  
    CAMELLIA OLEIFERA WHOLE (UNII: 1C0QTA61GT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54188-003-011 in 1 BOX03/29/2004
    130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/29/2004
    Labeler - WONG LAP KWONG MEDICINE COMPANY LIMITED (686530791)
    Establishment
    NameAddressID/FEIBusiness Operations
    WONG LAP KWONG MEDICINE COMPANY LIMITED686530791manufacture(54188-003)
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