Terrasil Balanitis Relief
Sulfur, Symphytum Officinale
Aidance Skincare & Topical Solutions, Llc
Human Otc Drug
NDC 24909-216Terrasil Balanitis Relief also known as Sulfur, Symphytum Officinale is a human otc drug labeled by 'Aidance Skincare & Topical Solutions, Llc'. National Drug Code (NDC) number for Terrasil Balanitis Relief is 24909-216. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Terrasil Balanitis Relief drug includes Sulfur - 1 [hp_X]/g Symphytum Officinale Whole - 1 [hp_X]/g . The currest status of Terrasil Balanitis Relief drug is Active.
Drug Information:
| Drug NDC: | 24909-216 |
| 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: | Terrasil Balanitis 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: | Sulfur, Symphytum Officinale |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Aidance Skincare & Topical Solutions, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| 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: | SULFUR - 1 [hp_X]/g
SYMPHYTUM OFFICINALE WHOLE - 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: | 03 Jun, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 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. |
| 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: | Aidance Skincare & Topical Solutions, 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. |
| UNII: | 70FD1KFU70
H8FJJ6KX5Y
|
| 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 |
|---|
| 24909-216-50 | 50 g in 1 TUBE (24909-216-50) | 03 Jun, 2016 | 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:
Product Elements:
Terrasil balanitis relief sulfur, symphytum officinale yellow wax bentonite allantoin cottonseed oil jojoba oil magnesium oxide coconut oil juniperus virginiana oil stearic acid silver oxide sunflower oil zinc oxide lavender oil sulfur sulfur symphytum officinale whole symphytum officinale whole
Indications and Usage:
Uses helps relieve irritated skin at the head of the penis.
Warnings:
Warnings for external use only. when using this product do not use in or near eyes. stop use and ask a doctor if symptoms last more than 3 days, symptoms worsen, or symptoms clear up and occur again within a few days. keep out of reach of children. if swallowed, call poison control or seek medical help right away.
Dosage and Administration:
Directions adults and children 2 years of age and older: apply to affected area 2 to 3 times per day or as needed. children under 2 years of age: consult a doctor. store at room temperature. may stain fabrics.
Package Label Principal Display Panel:
Product label image description
Further Questions:
Questions? 401-432-7750 or www.aidance.com