Avon Hexashield Arthritis Pain Relief Cream Capsaisin
Capsaisin
Tai Guk Pharm. Co., Ltd.
Human Otc Drug
NDC 43136-101Avon Hexashield Arthritis Pain Relief Cream Capsaisin also known as Capsaisin is a human otc drug labeled by 'Tai Guk Pharm. Co., Ltd.'. National Drug Code (NDC) number for Avon Hexashield Arthritis Pain Relief Cream Capsaisin is 43136-101. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Avon Hexashield Arthritis Pain Relief Cream Capsaisin drug includes Capsaicin - .75 mg/g . The currest status of Avon Hexashield Arthritis Pain Relief Cream Capsaisin drug is Active.
Drug Information:
| Drug NDC: | 43136-101 |
| 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: | Avon Hexashield Arthritis Pain Relief Cream Capsaisin |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Avon Hexashield Arthritis Pain Relief |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Cream Capsaisin |
| 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: | Capsaisin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Tai Guk Pharm. Co., Ltd. |
| 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: | CAPSAICIN - .75 mg/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: | 31 Jul, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 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: | Tai Guk Pharm. Co., Ltd.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 141868
|
| 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: | 0803954601015
|
| UPC stands for Universal Product Code. |
| UNII: | S07O44R1ZM
|
| 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 |
|---|
| 43136-101-01 | 1 TUBE in 1 CARTON (43136-101-01) / 42.5 g in 1 TUBE | 31 Jul, 2019 | 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:
Purpose topical analgesic
Product Elements:
Avon hexashield arthritis pain relief cream capsaisin capsaisin sorbitol water petrolatum benzyl alcohol capsaicin capsaicin alcohol polyoxyl 40 stearate sorbitan monostearate cetyl alcohol isopropyl myristate
Indications and Usage:
Uses for temporary relieves of minor aches and pains of muscles and joints associated with: arthritis simple backache bruises
Warnings:
Warnings for external use only. when using this product use only as directed do not apply to wounds, damaged, broken or irritated skin avoid contact with the eyes or mucous membranes a slight burning sensation may occur upon application, but generally disappears in several days if severe burning occurs, discontinue use do not expose the treated area to heat or direct sunlight do not banage do not use with heating pad stop use and ask a doctor if : condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness is present irritation develops keep out of reach of children. in case of accidental ingestion, get medical help or contact a poison control center right away.
When Using:
When using this product use only as directed do not apply to wounds, damaged, broken or irritated skin avoid contact with the eyes or mucous membranes a slight burning sensation may occur upon application, but generally disappears in several days if severe burning occurs, discontinue use do not expose the treated area to heat or direct sunlight do not banage do not use with heating pad
Dosage and Administration:
Directions adults and children over 18 years : apply generously to affected area not more than 3 to 4 times daily massage into painful area until thoroughly absorbed wash hands with soap and water after use close cap tightly after use children 18 years or younger : ask a doctor
Stop Use:
Stop use and ask a doctor if : condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness is present irritation develops
Package Label Principal Display Panel:
Principal display panel strong & effective pain relief arthritis pain relief high potency avon temporary relief of pain associated with: sprains pains of muscles and joints arthritis strains hexashield arthritis pain relief cream capsaicin add 0.075% deep penetratng & odor free arthritis pain relief topical analgesic cream net wt 1.5 oz (43.5 g) capsaicin capsaicin df
Further Questions:
Questions or comments? call toll free 1-800-for-avon www.avon.com