Sterillium Rub Fragrance Free
Alcohol
Bode Chemie Gmbh
Human Otc Drug
NDC 65616-008Sterillium Rub Fragrance Free also known as Alcohol is a human otc drug labeled by 'Bode Chemie Gmbh'. National Drug Code (NDC) number for Sterillium Rub Fragrance Free is 65616-008. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Sterillium Rub Fragrance Free drug includes Alcohol - 89.5 mL/100mL . The currest status of Sterillium Rub Fragrance Free drug is Active.
Drug Information:
| Drug NDC: | 65616-008 |
| 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: | Sterillium Rub Fragrance Free |
| 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: | Alcohol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bode Chemie 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 - 89.5 mL/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: | 31 Jul, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 13 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: | part333E |
| 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: | BODE Chemie GmbH
|
| 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: | 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 |
|---|
| 65616-008-06 | 1000 mL in 1 BOTTLE, PUMP (65616-008-06) | 31 Jul, 2019 | N/A | No |
| 65616-008-08 | 50 mL in 1 BOTTLE, SPRAY (65616-008-08) | 31 Jul, 2019 | 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 antiseptic
Product Elements:
Sterillium rub fragrance free alcohol water isopropyl alcohol myristyl alcohol glycerin alcohol alcohol
Indications and Usage:
Uses surgical hand antiseptic significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care
Warnings:
Warnings for external use only. flammable, keep away from fire or flame.
Do Not Use:
Warnings for external use only. flammable, keep away from fire or flame.
When Using:
When using this product and contact with the eyes occurs, flush immediately with water.
Dosage and Administration:
Directions apply to clean, dry hands for the first use of the day, use a nail pick dispense approx. 2 ml into hand, dip fingers of opposite hand into palm, working product under nails and into cuticles repeat procedure with other hand with hands still moist spread around the hand and lower 1/3 of the forearm reapply the product to the hands, paying particular attention to fingers, cuticles, and interdigital spaces following application, rub hands until dry hands should remain moist for entire application time, approx. 1.5 minutes.
Stop Use:
Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours
Package Label Principal Display Panel:
Bode sterillium rub fragrance-free procedural rub surgical hand antiseptic 85% w/w ethyl alcohol with emollients indication: significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care. fast-actng. dermatologically tested. gentle to skin. read drug facts panel before use. lot: use by: questions? call 1-800-medline ndc 65616-008-06 1000 ml 33.8 fl.oz. container label bsp2 container label fsp2 container label b2 container label f2