Soeder Hand Sanitizer
Ethyl Alcohol 70%
Soeder Gmbh
Human Otc Drug
NDC 80531-002Soeder Hand Sanitizer also known as Ethyl Alcohol 70% is a human otc drug labeled by 'Soeder Gmbh'. National Drug Code (NDC) number for Soeder Hand Sanitizer is 80531-002. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Soeder Hand Sanitizer drug includes Alcohol - 350 mL/500mL . The currest status of Soeder Hand Sanitizer drug is Active.
Drug Information:
| Drug NDC: | 80531-002 |
| 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: | Soeder Hand Sanitizer |
| 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: | Ethyl Alcohol 70% |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Soeder Gmbh |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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: | ALCOHOL - 350 mL/500mL
|
| 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: | 26 Feb, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 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: | part333A |
| 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: | Soeder GmbH
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 582753
|
| 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: | 0675051010317
0675051010324
|
| UPC stands for Universal Product Code. |
| UNII: | 3K9958V90M
|
| 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 |
|---|
| 80531-002-01 | 1 BOTTLE, PUMP in 1 BOX (80531-002-01) / 100 mL in 1 BOTTLE, PUMP | 26 Feb, 2021 | N/A | No |
| 80531-002-02 | 1 BOTTLE, PUMP in 1 BOX (80531-002-02) / 500 mL in 1 BOTTLE, PUMP | 26 Feb, 2021 | 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:
Ethyl alcohol 70% v/v.......................antiseptic
Product Elements:
Soeder hand sanitizer ethyl alcohol 70% alcohol alcohol water citric acid monohydrate santalum paniculatum wood oil lime peel lavandin oil cananga odorata leaf oil indian frankincense oil coriander oil glycerin juniperus deppeana wood oil rosemary aloe vera leaf sodium hydroxide abies alba leaf oil white pepper oil vetiver oil limonene, (+)-
Indications and Usage:
Hand sanitizer to help reduce bacteria on the skin. for use when soap and water are not available.
Warnings:
For external use only. flammable. keep away from heat or flame. do not use on children less than 2 months of age on open skin wounds when using this product keep out of eyes, ears, and mouth. in case of contact with eyes, rinse eyes thoroughly with water. stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
For external use only. flammable. keep away from heat or flame. do not use on children less than 2 months of age on open skin wounds when using this product keep out of eyes, ears, and mouth. in case of contact with eyes, rinse eyes thoroughly with water. stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product keep out of eyes, ears, and mouth. in case of contact with eyes, rinse eyes thoroughly with water.
Dosage and Administration:
Place enough product on hands to cover all surfaces. rub hands together until dry supervise children under 6 years of age when using this product to avoid swallowing
Stop Use:
Stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.
Package Label Principal Display Panel:
100 100 label 500 500 label
Further Questions:
Questions or comments? call 855-609-1262 monday through friday, 9am-5pm (gmt-4)