Kwan Loong
Methyl Salicylate And Menthol
Haw Par Healthcare Ltd.
Human Otc Drug
NDC 66761-311Kwan Loong also known as Methyl Salicylate And Menthol is a human otc drug labeled by 'Haw Par Healthcare Ltd.'. National Drug Code (NDC) number for Kwan Loong is 66761-311. This drug is available in dosage form of Oil. The names of the active, medicinal ingredients in Kwan Loong drug includes Menthol, Unspecified Form - 160 mg/mL Methyl Salicylate - 350 mg/mL . The currest status of Kwan Loong drug is Active.
Drug Information:
| Drug NDC: | 66761-311 |
| 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: | Kwan Loong |
| 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: | Methyl Salicylate And Menthol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Haw Par Healthcare 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: | MENTHOL, UNSPECIFIED FORM - 160 mg/mL
METHYL SALICYLATE - 350 mg/mL
|
| 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: | 01 Sep, 2005 |
| 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: | Haw Par Healthcare Ltd.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1374840
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0039278470109
|
| UPC stands for Universal Product Code. |
| UNII: | L7T10EIP3A
LAV5U5022Y
|
| 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 |
|---|
| 66761-311-01 | 1 BOTTLE in 1 BOX (66761-311-01) / 28 mL in 1 BOTTLE | 01 Sep, 2005 | N/A | No |
| 66761-311-22 | 1 BOTTLE in 1 BOX (66761-311-22) / 57 mL in 1 BOTTLE | 01 Sep, 2005 | 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 methyl salicylate 35% external analgesic menthol 16% external analgesic
Product Elements:
Kwan loong methyl salicylate and menthol methyl salicylate salicylic acid menthol, unspecified form menthol, unspecified form eucalyptus oil spike lavender oil light mineral oil
Indications and Usage:
Uses for temporary relief of minor aches and pains of muscles and joints associated with simple backaches, arthritis, bruises, sprain and strains.
Warnings:
Warnings for external use only. when using this product use only as directed avoid contact with eyes and mucous membranes do not apply to open wounds, damaged or irritated skin do not bandage or cover with any type of wrap except clothing do not use with heating pad or apply external heat do not use 1 hour prior to bathing or within 30 minutes after bathing. stop use and ask a doctor if condition worsens pain persists for more than seven days pain clears up and then recurs a few days later severe skin irritation occurs. if pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center immediately.
When Using:
When using this product use only as directed avoid contact with eyes and mucous membranes do not apply to open wounds, damaged or irritated skin do not bandage or cover with any type of wrap except clothing do not use with heating pad or apply external heat do not use 1 hour prior to bathing or within 30 minutes after bathing.
Dosage and Administration:
Directions adults and children 12 years of age or older, apply to the affected areas not more than 3 to 4 times daily for children under 12 years old consult a doctor before use.
Stop Use:
Stop use and ask a doctor if condition worsens pain persists for more than seven days pain clears up and then recurs a few days later severe skin irritation occurs.
Package Label Principal Display Panel:
Principal display panel - 57 ml bottle box ndc 66761-311-22 kwan loong ® pain relieving oil for temporary relief of minor aches and pains of muscles and joints associated with simple backaches, arthritis, bruises, sprain and strains. 2 fl. oz. (57ml) principal display panel - 57 ml bottle box
Further Questions:
Questions (925) 292-3888