Antibacterial Wipes
Benzalkonium Chloride
Tat Kimya Sabun Ve Gliserin Sanayi Ve Ticaret Anonim Sirketi
Human Otc Drug
NDC 76964-200Antibacterial Wipes also known as Benzalkonium Chloride is a human otc drug labeled by 'Tat Kimya Sabun Ve Gliserin Sanayi Ve Ticaret Anonim Sirketi'. National Drug Code (NDC) number for Antibacterial Wipes is 76964-200. This drug is available in dosage form of Cloth. The names of the active, medicinal ingredients in Antibacterial Wipes drug includes Benzalkonium Chloride - .13 g/100g . The currest status of Antibacterial Wipes drug is Active.
Drug Information:
| Drug NDC: | 76964-200 |
| 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: | Antibacterial Wipes |
| 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: | Benzalkonium Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Tat Kimya Sabun Ve Gliserin Sanayi Ve Ticaret Anonim Sirketi |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cloth |
| 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: | BENZALKONIUM CHLORIDE - .13 g/100g
|
| 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: | 03 Jun, 2020 |
| 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: | 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: | TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI
|
| 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. |
| UPC: | 8694965538597
|
| UPC stands for Universal Product Code. |
| UNII: | F5UM2KM3W7
|
| 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 |
|---|
| 76964-200-11 | 60 POUCH in 1 PACKAGE (76964-200-11) / 5 g in 1 POUCH | 03 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 antibacterial, wet wipes
Product Elements:
Antibacterial wipes benzalkonium chloride c12-15 pareth-12 propylene glycol polysorbate 20 piroctone olamine glycerin edetate sodium panthenol .alpha.-tocopherol acetate water citric acid monohydrate benzalkonium chloride benzalkonium
Indications and Usage:
Use antibacterial wet wipes helps reduce bacteria (organisms). effective on bacterias : staphylococcus aureus atcc 6538, pseudomonas aeruginosa atcc 15442, enterococcus hirae atcc 10541, escherichia coli atcc 10536
Warnings:
Warnings keep away from children and direct sunlight. children should not use this product without an adult supervision. for external use only. in case of poisoning, call the national toxitation information center. awoid contact with eyes.
Do Not Use:
Warnings keep away from children and direct sunlight. children should not use this product without an adult supervision. for external use only. in case of poisoning, call the national toxitation information center. awoid contact with eyes.
When Using:
In case of inhaling: if you feel uncomfortable get some fresh ait. in case of skin irritation: occurs stop using the wipes immediately and wash the affected area with water and soap for at least 15 minutes. people with sensitive skin, pregnant women, breastfeeding women and children under the age of 12 should consult a doctor/pharmacist before using the product. seek for medical advice if necessary. in case of contact with eyes: if you are wearing contact lenses, remove them immediately. rince your eyes with plenty of clean water. in case of swallowing: call your local toxication center and get medical help. there is no specific antidote therefore treatment must be done according to symptoms. treatment: treatment is indicated according to the indication. call your local poison center.
Dosage and Administration:
Directions provides practical cleaning without need of water and soap. used for hand cleaning. open the adhesive label and pick up a wipe. gently wipe your hands with antibacterial wipe. no rinsing required. user group : general public
Stop Use:
Treatment is indicated according to the indication. call your local poison center
Package Label Principal Display Panel:
Package label - principal display panel 60 pcs. ndc : 76964-200