Zostrix High Potency Foot Pain Relief
Capsaicin
Medtech Products Inc
Human Otc Drug
NDC 61787-556Zostrix High Potency Foot Pain Relief also known as Capsaicin is a human otc drug labeled by 'Medtech Products Inc'. National Drug Code (NDC) number for Zostrix High Potency Foot Pain Relief is 61787-556. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Zostrix High Potency Foot Pain Relief drug includes Capsaicin - .75 mg/g . The currest status of Zostrix High Potency Foot Pain Relief drug is Active.
Drug Information:
| Drug NDC: | 61787-556 |
| 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: | Zostrix High Potency Foot Pain Relief |
| 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: | Capsaicin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Medtech Products 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: | 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: | 22 Oct, 2013 |
| 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: | MEDTECH PRODUCTS INC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| 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 |
|---|
| 61787-556-02 | 1 TUBE in 1 CARTON (61787-556-02) / 56.6 g in 1 TUBE | 22 Oct, 2013 | 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:
Zostrix high potency foot pain relief capsaicin capsaicin capsaicin isopropyl myristate water sorbitol cetyl alcohol petrolatum glyceryl monostearate peg-100 stearate benzyl alcohol
Indications and Usage:
Uses for the temporary relief of minor aches and pains of the muscles and joints associated with strains sprains bruises arthritis
Warnings:
Warnings for external use only. do not apply to wounds or to damaged or irritated skin. when using this product you may experience a burning sensation which is normal and related to the way the product works. with regular use, this sensation generally diminishes. avoid contact with eyes. do not get it on mucous membranes, into eyes, or on contact lenses. if this occurs, rinse the affected area thoroughly with water. do not apply immediately before or after activities such as bathing, swimming, sun bathing, or strenuous exercise. do not apply heat to the treated areas immediately before or after use. do not tightly wrap or bandage the treated area. avoid inhaling airborne material from dried residue. this can result in coughing, sneezing, tearing, throat or respiratory irritation. stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. blistering occurs. difficulty breathing or swallowing occurs. severe b
Read more...urning persists. keep out of reach of children. if swallowed, get medical help or contact a poison control center immediately.
When Using:
When using this product you may experience a burning sensation which is normal and related to the way the product works. with regular use, this sensation generally diminishes. avoid contact with eyes. do not get it on mucous membranes, into eyes, or on contact lenses. if this occurs, rinse the affected area thoroughly with water. do not apply immediately before or after activities such as bathing, swimming, sun bathing, or strenuous exercise. do not apply heat to the treated areas immediately before or after use. do not tightly wrap or bandage the treated area. avoid inhaling airborne material from dried residue. this can result in coughing, sneezing, tearing, throat or respiratory irritation.
Dosage and Administration:
Directions for persons under 18 years of age, ask a doctor before using. apply a thin film of cream to the affected area and gently rub in until fully absorbed. for optimum relief, apply 3 to 4 times daily best results typically occur after 2 to 4 weeks of continuous use. wash hands thoroughly with soap and water immediately after use. see package insert for more information.
Stop Use:
Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. blistering occurs. difficulty breathing or swallowing occurs. severe burning persists.
Package Label Principal Display Panel:
Package/label principal display panel maximum strength zostrix ® natural foot pain relief capsaicin 0.1% topical anagesic blocks your bodyâs pain messenger odor free cream warmth from chili peppers net wt. 2 oz. (57 g ) maximum strength zostrix® natural foot pain relief capsaicin 0.1% topical anagesic blocks your bodyâs pain messenger ⢠odor free cream ⢠warmth from chili peppers net wt. 2 oz. (57 g)
Further Questions:
Questions or comments? call: 1-800-579-8327 serious side effects associated with the use of this product may be reported to this number. zostrix.com