Tiger Balm Arthritis Rub
Camphor (synthetic) And Menthol
Prince Of Peace Enterprises, Inc.
Human Otc Drug
NDC 62003-422Tiger Balm Arthritis Rub also known as Camphor (synthetic) And Menthol is a human otc drug labeled by 'Prince Of Peace Enterprises, Inc.'. National Drug Code (NDC) number for Tiger Balm Arthritis Rub is 62003-422. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Tiger Balm Arthritis Rub drug includes Camphor (synthetic) - 110 mg/mL Menthol, Unspecified Form - 110 mg/mL . The currest status of Tiger Balm Arthritis Rub drug is Active.
Drug Information:
| Drug NDC: | 62003-422 |
| 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 Arthritis Rub |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Tiger Balm |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Arthritis Rub |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Prince Of Peace Enterprises, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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) - 110 mg/mL
MENTHOL, UNSPECIFIED FORM - 110 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: | 10 Jun, 2002 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 28 Feb, 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: | 16 Jan, 2025 |
| 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: | Prince of Peace Enterprises, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1089831
|
| 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 |
|---|
| 62003-422-02 | 2 mL in 1 PACKET (62003-422-02) | 10 Jun, 2002 | 28 Feb, 2026 | No |
| 62003-422-04 | 1 BOTTLE, PUMP in 1 CARTON (62003-422-04) / 113 mL in 1 BOTTLE, PUMP | 10 Jun, 2002 | 28 Feb, 2026 | 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 11% topical analgesic menthol 11% topical analgesic
Product Elements:
Tiger balm arthritis rub camphor (synthetic) and menthol camphor (synthetic) camphor (synthetic) menthol, unspecified form menthol, unspecified form cajuput oil chondroitin sulfate (bovine) cinnamon oil clove oil water diazolidinyl urea glucosamine sulfate methylparaben dimethyl sulfone peg-120 methyl glucose dioleate propylparaben propylene glycol
Indications and Usage:
Uses for the temporary relief of minor aches and pains associated with arthritis, backache, stiffness, muscle strains and sprains.
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 wounds, damaged or irritated skin do not bandage or cover with wrap or use heating pad do not use 1 hour prior to bathing or within 30 minutes after bathing. stop use and ask a doctor if condition worsens severe skin irritation occurs pain persists for more than 7 days pain clears up and then recurs a few days later. 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 wounds, damaged or irritated skin do not bandage or cover with wrap or use heating pad do not use 1 hour prior to bathing or within 30 minutes after bathing.
Dosage and Administration:
Directions shake well before using apply generously to affected areas and massage gently until cream is absorbed into the skin for adults and children over 12, rub well on the affected area. repeat 3-4 times daily for children 12 years of age or younger, consult a doctor before use.
Stop Use:
Stop use and ask a doctor if condition worsens severe skin irritation occurs pain persists for more than 7 days pain clears up and then recurs a few days later.
Package Label Principal Display Panel:
Principal display panel - 113ml bottle carton ndc 62003-422-04 tiger balm ® easy to use pump tiger balm ® arthritis rub effective arthritis pain relieving cream containing: camphor, menthol alcohol-free net 4 fl oz (113ml) principal display panel - 113ml bottle carton
Further Questions:
Questions/comments (510) 887-1899