Careall Arthritis And Muscle
Capsaicin
New World Imports, Inc
Human Otc Drug
NDC 51824-094Careall Arthritis And Muscle also known as Capsaicin is a human otc drug labeled by 'New World Imports, Inc'. National Drug Code (NDC) number for Careall Arthritis And Muscle is 51824-094. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Careall Arthritis And Muscle drug includes Capsaicin - .025 g/g . The currest status of Careall Arthritis And Muscle drug is Active.
Drug Information:
| Drug NDC: | 51824-094 |
| 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: | Careall Arthritis And Muscle |
| 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: | New World Imports, 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 - .025 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: | 01 Jun, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 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: | New World Imports, Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 198555
|
| 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: | 0085317009533
|
| 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 |
|---|
| 51824-094-15 | 42.5 g in 1 TUBE (51824-094-15) | 01 Jun, 2022 | 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:
Careall arthritis and muscle capsaicin capsaicin capsaicin benzyl alcohol cetyl alcohol anhydrous citric acid glyceryl stearate/peg-100 stearate isopropyl myristate peg-100 stearate petrolatum water sorbitol
Indications and Usage:
Uses for the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backaches, strains, and sprains
Warnings:
Warnings warnings. for external use only. read all warnings and directions before use. tet first on small area of skin. do not use on wounds or damaged skin if you are allergic to capsicum or chili peppers when using this product you may experience a burning sensation. the intensity of this reaction varies among individuals and may be severe. with regular use, this sensation generally disappears after several days avoid contact with the eyes, lips, nose or mucous membranes. if this occurs, rinse the affected area thoroughly with water do no apply immediately before or after activites such as bathing, swimming, sunbathing, or strenuous exercise do not tightly wrap or bandage the treated area do no apply heat to the treated area immediately before or after use do not use with a heating pad or on wounds, damaged, broken (open) or irritated skin avoid inhaling airborne material from dried residue. this can result in coughing, sneezing, tearing, or throat/respiratory irritation stop use and
Read more... ask a doctor if: condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days severe burning persists, or blistering occurs difficulty breathing or swallowing occurs if pregnant or breast feeding, ask a health professional before use.
Dosage and Administration:
Directions directions adults and children 18 years of age and older: apply a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands, wash hand thoroughly with soap and water immediately after application for best results, apply 3 to 4 times daily children 18 years of age and younger: ask a doctor
Package Label Principal Display Panel:
Cap15 carton label