Koong Yick Hak Kwai Oil
Turpentine Oil
Ling Nam Medicine Factory (h.k.) Ltd.
Human Otc Drug
NDC 57598-221Koong Yick Hak Kwai Oil also known as Turpentine Oil is a human otc drug labeled by 'Ling Nam Medicine Factory (h.k.) Ltd.'. National Drug Code (NDC) number for Koong Yick Hak Kwai Oil is 57598-221. This drug is available in dosage form of Oil. The names of the active, medicinal ingredients in Koong Yick Hak Kwai Oil drug includes Turpentine - 46 g/100mL . The currest status of Koong Yick Hak Kwai Oil drug is Active.
Drug Information:
| Drug NDC: | 57598-221 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Koong Yick Hak Kwai Oil |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Turpentine Oil |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Ling Nam Medicine Factory (h.k.) Ltd. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Oil |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | TURPENTINE - 46 g/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 25 Feb, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part348 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Ling Nam Medicine Factory (H.K.) Ltd.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 4892758040607
|
| UPC stands for Universal Product Code. |
| UNII: | XJ6RUH0O4G
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 57598-221-02 | 1 BOTTLE in 1 BOX (57598-221-02) / 60 mL in 1 BOTTLE | 25 Feb, 2021 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Active ingredients purpose turpentine 46% external analgesic
Product Elements:
Koong yick hak kwai oil turpentine oil light mineral oil thyme oil turpentine turpentine d&c yellow no. 11 d&c green no. 6 d&c red no. 17 d&c violet no. 2
Indications and Usage:
Uses for temporary relief of minor aches and pains of muscles and joints due to: arthritis strains bruises sprains simple backache
Warnings:
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.
Do Not Use:
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.
When Using:
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
Dosage and Administration:
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.
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 redness is present
Package Label Principal Display Panel:
Principal display panel - 2oz (60 ml) ndc.no : 57598-221-02 koong yick hak kwai oil external analgesic ling nam medicine factory (h.k.) limited tuen mun, new territories, hong kong, china sole distributor tcm herbalway inc., covina, ca 91724, usa 60ml kyhk
Further Questions:
Questions? +1-626-823-9933 m-f 9am to 5pm pacific time. you may report serious side effects to this phone number.