Aldamed
Sundermia Sun-exposure Skin Relief Gel
Green Idea S.r.o.
Human Otc Drug
NDC 82810-114Aldamed also known as Sundermia Sun-exposure Skin Relief Gel is a human otc drug labeled by 'Green Idea S.r.o.'. National Drug Code (NDC) number for Aldamed is 82810-114. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Aldamed drug includes Menthol - 3 mg/100mL . The currest status of Aldamed drug is Active.
Drug Information:
| Drug NDC: | 82810-114 |
| 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: | Aldamed |
| 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: | Sundermia Sun-exposure Skin Relief Gel |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Green Idea S.r.o. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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: | MENTHOL - 3 mg/100mL
|
| 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: | 06 Sep, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| 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: | Green Idea s.r.o.
|
| 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: | L7T10EIP3A
|
| 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 |
|---|
| 82810-114-11 | 200 mL in 1 TUBE (82810-114-11) | 06 Sep, 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:
Topical analgesic
Product Elements:
Aldamed sundermia sun-exposure skin relief gel lavandula angustifolia flower .alpha.-tocopherol acetate arnica montana flower yeast .beta.-d-glucan biosaccharide gum-1 d&c orange no. 4 ethylhexylglycerin hypericum perforatum avocado oil apricot kernel oil sodium hydroxide grape seed oil water calendula officinalis flower carboxypolymethylene chamomile menthol menthol shea butter hamamelis virginiana leaf macadamia oil aloe vera leaf babassu oil glycereth-8 esters rosa canina fruit oil rosemary oil bilberry phenoxyethanol polysorbate 80 almond oil jojoba oil camellia sinensis flower centella asiatica triterpenoids glycerin hippophae rhamnoides fruit hydrogenated palm glycerides melissa officinalis flowering top panthenol
Indications and Usage:
Use temporary relief of pain from sunburn, minor burns, bruises, and scrapes.
Warnings:
Warnings for external use only. keep away from heat or flame.
Do Not Use:
Warnings for external use only. keep away from heat or flame.
When Using:
When using this product do not use it in or near the eyes or mouth.
Dosage and Administration:
Directions apply on the affected area and rub gently till absorbed. apply up to 3 times daily. do no use on children below the age of 3 years old
Stop Use:
Stop use and ask a doctor if irritation, itching, or rash occurs.
Package Label Principal Display Panel:
200 ml ndc: 82810-114-11 sundermia