NDC 57598-223 Ling Nam Hak Kwai Oil

Turpentine Oil

NDC Product Code 57598-223

NDC 57598-223-02

Package Description: 1 BOTTLE in 1 BOX > 60 mL in 1 BOTTLE

NDC Product Information

Ling Nam Hak Kwai Oil with NDC 57598-223 is a a human over the counter drug product labeled by Ling Nam Medicine Factory (h.k.) Ltd.. The generic name of Ling Nam Hak Kwai Oil is turpentine oil. The product's dosage form is oil and is administered via topical form.

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Ling Nam Hak Kwai Oil Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • D&C RED NO. 17 (UNII: ND733RX3JN)
  • D&C YELLOW NO. 11 (UNII: 44F3HYL954)
  • D&C VIOLET NO. 2 (UNII: 350KA7O6HK)
  • D&C GREEN NO. 6 (UNII: 4QP5U84YF7)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Ling Nam Medicine Factory (h.k.) Ltd.
Labeler Code: 57598
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-25-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Ling Nam Hak Kwai Oil Product Label Images

Ling Nam Hak Kwai Oil Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index


Drug Facts

Otc - Purpose

Active IngredientsPurposeTurpentine 46%External analgesic


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


For external use only

Do Not Use

  • On woundsirritated or damaged skinsensitive skinwith a heating padwith, or at the same time as, other external analgesic productsif allergic to any ingredients of this productif pregnant

When Using This Product

  • Avoid contact with the eyes or on mucous membranesdo not bandage tightlydo not apply to wounds or damaged skindo not use 1 hour before or after bathing

Stop Use And Ask A Doctor If

  • Condition worsenssymptoms persist for more than 7 dayssymptoms clear up and occur again within a few daysexcessive irritation of the skin developsredness is present

Otc - Pregnancy Or Breast Feeding

If pregnant, ask health professional before use.

Otc - Keep Out Of Reach Of Children

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.


  • 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, Java Citronella Oil, Light mineral oil, Thyme oil


+1-626-823-9933M-F 9am to 5pm Pacific Time. You may report serious side effects to this phone number.

* Please review the disclaimer below.