Tiger Balm
Camphor (synthetic) And Menthol
Haw Par Healthcare Ltd.
Human Otc Drug
NDC 66761-321Tiger Balm also known as Camphor (synthetic) And Menthol is a human otc drug labeled by 'Haw Par Healthcare Ltd.'. National Drug Code (NDC) number for Tiger Balm is 66761-321. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Tiger Balm drug includes Camphor (synthetic) - 230 mg/1 Menthol, Unspecified Form - 70 mg/1 . The currest status of Tiger Balm drug is Active.
Drug Information:
| Drug NDC: | 66761-321 |
| 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: | Tiger Balm |
| 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: | Camphor (synthetic) 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: | Patch |
| 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: | CAMPHOR (SYNTHETIC) - 230 mg/1
MENTHOL, UNSPECIFIED FORM - 70 mg/1
|
| 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: | 15 Jan, 2007 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 2025 |
| 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: | 853139
|
| 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. |
| UNII: | 5TJD82A1ET
L7T10EIP3A
|
| 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 |
|---|
| 66761-321-04 | 1 POUCH in 1 BOX (66761-321-04) / 4 PATCH in 1 POUCH | 15 Jan, 2007 | 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 camphor 230mg / patch topical analgesic menthol 70mg / patch topical analgesic
Product Elements:
Tiger balm camphor (synthetic) and menthol camphor (synthetic) camphor (synthetic) menthol, unspecified form menthol, unspecified form eucalyptus oil glycerin polysorbate 80 carboxymethylcellulose sodium, unspecified form sorbitan monooleate sorbitol tartaric acid water
Indications and Usage:
Uses for temporary relief of pains.
Warnings:
Warnings for external use only when using this product use only as directed do not get into eyes or on mucous membranes do not apply to wounds, damaged or irritated skin do not bandage or cover with any type of wrap except clothing do not use with a heating pad or apply external heat do not use 1 hour prior to bathing or 30 minutes after bathing stop use and ask a doctor if condition worsens severe skin irritation occurs pain persists for more than 7 days if pregnant or breast-feeding, ask a healthcare professional before use. keep out of reach of children. if swallowed, get medical help or contact poison control center right away.
When Using:
When using this product use only as directed do not get into eyes or on mucous membranes do not apply to wounds, damaged or irritated skin do not bandage or cover with any type of wrap except clothing do not use with a heating pad or apply external heat do not use 1 hour prior to bathing or 30 minutes after bathing
Dosage and Administration:
Directions adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily children under 12 years, consult doctor before use how to apply: clean and dry affected area cut open pouch and remove patch remove protective film and apply directly to area of pain apply to affected area not more than 3 times daily wash hands with soap after applying patch reseal pouch containing unused patches
Stop Use:
Stop use and ask a doctor if condition worsens severe skin irritation occurs pain persists for more than 7 days
Package Label Principal Display Panel:
Principal display panel - 4 patch carton ndc 66761-321-04 tiger balm ® large tiger balm ® pain relieving large patch advanced hydrogel patch technology stretchable long lasting convenient and not messy it works! 4 patches (8 x 4 inches each) principal display panel - 4 patch carton
Further Questions:
Questions/comments (510) 887-1899