Detrox Detroderm Gel Hand And Skin Antiseptic
Isopropyl Alcohol
Detro Healthcare Kimya Sanayi Anonim Sirketi
Human Otc Drug
NDC 79506-101Detrox Detroderm Gel Hand And Skin Antiseptic also known as Isopropyl Alcohol is a human otc drug labeled by 'Detro Healthcare Kimya Sanayi Anonim Sirketi'. National Drug Code (NDC) number for Detrox Detroderm Gel Hand And Skin Antiseptic is 79506-101. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Detrox Detroderm Gel Hand And Skin Antiseptic drug includes Isopropyl Alcohol - 70 mL/100mL . The currest status of Detrox Detroderm Gel Hand And Skin Antiseptic drug is Active.
Drug Information:
| Drug NDC: | 79506-101 |
| 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: | Detrox Detroderm Gel Hand And Skin Antiseptic |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Detrox |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | DETRODERM Gel HAND AND SKIN ANTISEPTIC |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Isopropyl Alcohol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Detro Healthcare Kimya Sanayi Anonim Sirketi |
| 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: | ISOPROPYL ALCOHOL - 70 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: | 30 Jun, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 04 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: | DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 581698
|
| 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. |
| UNII: | ND2M416302
|
| 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 |
|---|
| 79506-101-01 | 100 mL in 1 BOTTLE (79506-101-01) | 30 Jun, 2020 | N/A | No |
| 79506-101-02 | 250 mL in 1 BOTTLE (79506-101-02) | 30 Jun, 2020 | N/A | No |
| 79506-101-03 | 500 mL in 1 BOTTLE (79506-101-03) | 30 Jun, 2020 | N/A | No |
| 79506-101-04 | 1000 mL in 1 BOTTLE (79506-101-04) | 30 Jun, 2020 | N/A | No |
| 79506-101-05 | 5000 mL in 1 CAN (79506-101-05) | 30 Jun, 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:
Purpose antiseptic
Product Elements:
Detrox - detroderm gel hand and skin antiseptic isopropyl alcohol isopropyl alcohol isopropyl alcohol butylene glycol glycerin carbomer homopolymer, unspecified type water
Indications and Usage:
Uses hygienic and surgical antisepsis of hands and skin. it is used at all health institutions like surgery, intensive care, clinics, dental clinics, laboratory, veterinary, patient care at home.
Warnings:
Warnings flammable. keep out of ignition sources directly. do not use before reading user manual after 6 months from cover opening when using this product no smoking. must not be contacted with powerful oxidants, alkali metals due to fire and explosion possibility. keep out of reach of children, food, and animal foods. keep out of ignition sources directly. do not stock with oxidant and spontaneously combustible materials. obey instructions existed in user manual. stop use and ask a doctor if *in case of poisoning *in case of ingestion *in case of contact with eyes keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions for hygienic hand antisepsis, at least 3 ml solution is applied to hand without dilution and hands are rubbed until drying. for surgical hand antisepsis, 5 ml solution is applied to hand.
Package Label Principal Display Panel:
Packaging detrox101
Further Questions:
Questions you may also report serious side effects to this phone number (+1-xxx-xxx-xxxx) mon-fri 9:00 am - 5:00 pm