African Black Eczema Therapy
Aloe, Centella Asiatica
Sundial Group Llc
Human Otc Drug
NDC 58666-3124African Black Eczema Therapy also known as Aloe, Centella Asiatica is a human otc drug labeled by 'Sundial Group Llc'. National Drug Code (NDC) number for African Black Eczema Therapy is 58666-3124. This drug is available in dosage form of Soap. The names of the active, medicinal ingredients in African Black Eczema Therapy drug includes Aloe - 4 [hp_X]/g Centella Asiatica - 1 [hp_X]/g . The currest status of African Black Eczema Therapy drug is Active.
Drug Information:
| Drug NDC: | 58666-3124 |
| 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: | African Black Eczema Therapy |
| 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: | Aloe, Centella Asiatica |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Sundial Group Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Soap |
| 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: | ALOE - 4 [hp_X]/g
CENTELLA ASIATICA - 1 [hp_X]/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: | UNAPPROVED HOMEOPATHIC |
| 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: | 21 May, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 13 Jun, 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. |
| Listing Expiration Date: | 31 Dec, 2024 |
| 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: | Sundial Group LLC
|
| 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. |
| UPC: | 0764302270409
|
| UPC stands for Universal Product Code. |
| UNII: | V5VD430YW9
7M867G6T1U
|
| 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 |
|---|
| 58666-3124-5 | 141 g in 1 PACKAGE (58666-3124-5) | 21 May, 2020 | 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:
Aloe (4x) hpus.....................................eczema hydrocotyle asiatica (tinc) hpus.........itching the letters hpus indicate that this ingredient is officially included in the homeopathic pharmacopoeia of the united states.
Product Elements:
African black eczema therapy aloe, centella asiatica sodium palm kernelate water glycerin palmitic acid shea butter salix alba bark cocoa oatmeal tea tree oil sodium chloride edetate sodium etidronate tetrasodium fucus vesiculosus centella asiatica centella asiatica melissa officinalis aloe aloe alcohol phenoxyethanol sodium cocoate activated charcoal sodium palmate
Indications and Usage:
Uses: for temporary relief of the symptoms of mild eczema and itching.
Warnings:
For external use only. ask a doctor before use is you have an overactive thyroid. do not use if pregnant, nursing, or for long term use. avoid use in eyes or eye area. if irritation occurs, stop use. ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Avoid use in eyes or eye area. if irritation occurs, stop use.
If swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions: lather in hands or on a washcloth and wash body. rinse thoroughly. gentle enough for daily use.
Stop Use:
Ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.
Package Label Principal Display Panel:
Carton
Further Questions:
Questions? 631-842-8800 or visit www.sheamoisture.com