Pain Terminator Analgesic
Topical Analgesic
Golden Sunshine International, Inc.
Human Otc Drug
NDC 67475-312Pain Terminator Analgesic also known as Topical Analgesic is a human otc drug labeled by 'Golden Sunshine International, Inc.'. National Drug Code (NDC) number for Pain Terminator Analgesic is 67475-312. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Pain Terminator Analgesic drug includes Menthol - .03 g/g Methyl Salicylate - .005 g/g . The currest status of Pain Terminator Analgesic drug is Active.
Drug Information:
| Drug NDC: | 67475-312 |
| 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: | Pain Terminator Analgesic |
| 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: | Topical Analgesic |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Golden Sunshine International, Inc. |
| 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: | MENTHOL - .03 g/g
METHYL SALICYLATE - .005 g/g
|
| 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: | 18 May, 2006 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 Dec, 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: | Golden Sunshine International, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1421024
|
| 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: | 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 |
|---|
| 67475-312-01 | 50 POUCH in 1 BOX (67475-312-01) / 5 PATCH in 1 POUCH / 3 g in 1 PATCH | 18 May, 2006 | N/A | No |
| 67475-312-02 | 10 PATCH in 1 BAG (67475-312-02) / 3 g in 1 PATCH | 18 May, 2006 | 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:
Topical analgesic
Product Elements:
Pain terminator analgesic topical analgesic menthol menthol methyl salicylate salicylic acid sesame oil pinus massoniana resin paeonia veitchii root zinc oxide drynaria fortunei root angelica sinensis root carthamus tinctorius flower bud pyritidium daemonorops draco resin frankincense myrrh larix decidua resin ligusticum sinense root achyranthes bidentata root eleutherococcus nodiflorus root bark acorus calamus root atractylodes japonica root schorl tourmaline saussurea costus root gentiana macrophylla root cnidium officinale root chinese cinnamon aconitum carmichaelii root pinellia ternata root dendrobium nobile stem tokoro yam fd&c blue no. 2 fd&c yellow no. 5
Indications and Usage:
Indications for the temporary relief of minor aches of muscles and joints associated with: simple backache arthritis strains bruises sprains menstrual pain
Warnings:
Warnings for external use only avoid contact with eyes or mucous membranes. do not apply to wounds or damaged or irritated skin. do not use if skin is sensitive, or have allergies to any ingredients in this product. discontinue use and consult a doctor if signs of irritation or rash appear. avoid use on extremely hairy areas of the body as removal may remove hair. if pregnant or breast feeding consult a doctor before use. keep out of reach of children.
Do Not Use:
Warnings for external use only avoid contact with eyes or mucous membranes. do not apply to wounds or damaged or irritated skin. do not use if skin is sensitive, or have allergies to any ingredients in this product. discontinue use and consult a doctor if signs of irritation or rash appear. avoid use on extremely hairy areas of the body as removal may remove hair. if pregnant or breast feeding consult a doctor before use. keep out of reach of children.
Dosage and Administration:
Directions for adults and children 6 and older. clean the affected area before use. can be cut to size. peel off film and cover affected area with patch. for menstrual pain, place on abdomen. keep on for up to 8 hours under normal conditions. apply once or twice per day as needed. allow skin to breath for a few hours between applications. users with sensitive skin should test on a small area first.
Package Label Principal Display Panel:
Pain terminator pouch for 5 patches. pouch for pain terminator patches.jpg
Further Questions:
For questions or comments call: 1 (800) 798-3977