Label: KOONG YICK HAK KWAI OIL- turpentine oil oil

  • NDC Code(s): 57598-221-02
  • Packager: Ling Nam Medicine Factory (H.K.) Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 30, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Turpentine 46%External analgesic

  • Uses

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

    • arthritis
    • strains
    • bruises
    • sprains
    • simple backache
  • Warnings

    For external use only

    Do not use

    • on wounds
    • irritated or damaged skin
    • sensitive skin
    • with a heating pad
    • with, or at the same time as, other external analgesic products
    • if allergic to any ingredients of this product
    • if pregnant

    When using this product

    • avoid contact with the eyes or on mucous membranes
    • do not bandage tightly
    • do not apply to wounds or damaged skin
    • do not use 1 hour before or after bathing

    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
    • redness is present

    If pregnant, ask health professional before use.

    Keep out of reach of children to avoid accidental poisoning.

    If swallowed, get medical help or contact Poison Control Center right away.

    Do not use otherwise than as directed.

  • Directions

    • Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    • Children under 12 years of age: Do not use or consult a doctor.
  • Other information

    • Store in a cool place
    • Close tightly after each use
  • Inactive ingredients

    D&C Green No.6, D&C Red No.17, D&C Violet No.2, D&C Yellow No.11, Light Mineral Oil, Thyme oil

  • Questions?

    +1-888-915-6789

    M-F 9am to 5pm Pacific Time.

    You may report serious side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Ling Nam Medicine Factory (H.K.) Limited
    Tuen Mun, New Territories, Hong Kong, China

  • PRINCIPAL DISPLAY PANEL - 60 ml Bottle Box

    NDC No. : 57598-221-02

    KOONG YICK
    HAK KWAI OIL

    EXTERNAL ANALGESIC
    2 FI. Oz. (60ml)

    PRINCIPAL DISPLAY PANEL - 60 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    KOONG YICK HAK KWAI OIL 
    turpentine oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57598-221
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TURPENTINE (UNII: XJ6RUH0O4G) (TURPENTINE - UNII:XJ6RUH0O4G) TURPENTINE46 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    THYME OIL (UNII: 2UK410MY6B)  
    D&C YELLOW NO. 11 (UNII: 44F3HYL954)  
    D&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
    D&C RED NO. 17 (UNII: ND733RX3JN)  
    D&C VIOLET NO. 2 (UNII: 350KA7O6HK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57598-221-021 in 1 BOX02/25/2021
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01702/25/2021
    Labeler - Ling Nam Medicine Factory (H.K.) Ltd. (667152748)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ling Nam Medicine Factory (H.K.) Ltd.667152748manufacture(57598-221)
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