Microsure Wound Care
Benzalkonium Chloride.
Strategia Project Management, Inc.
Human Otc Drug
NDC 72513-100Microsure Wound Care also known as Benzalkonium Chloride. is a human otc drug labeled by 'Strategia Project Management, Inc.'. National Drug Code (NDC) number for Microsure Wound Care is 72513-100. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Microsure Wound Care drug includes Benzalkonium Chloride - .13 g/100mL . The currest status of Microsure Wound Care drug is Active.
Drug Information:
| Drug NDC: | 72513-100 |
| 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: | Microsure Wound Care |
| 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: | Strategia Project Management, Inc. |
| 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: | BENZALKONIUM CHLORIDE - .13 g/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: | 28 Aug, 2018 |
| 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: | Strategia Project Management, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1020365
|
| 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: | 0372513001158
|
| 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 |
|---|
| 72513-100-01 | 50 mL in 1 BOTTLE, PUMP (72513-100-01) | 28 Aug, 2018 | N/A | Yes |
| 72513-100-02 | 125 mL in 1 BOTTLE, PUMP (72513-100-02) | 28 Aug, 2018 | N/A | No |
| 72513-100-03 | 250 mL in 1 BOTTLE, PUMP (72513-100-03) | 28 Aug, 2018 | N/A | No |
| 72513-100-04 | 59.14 mL in 1 BOTTLE, PUMP (72513-100-04) | 28 Aug, 2018 | N/A | No |
| 72513-100-05 | 59.14 mL in 1 BOTTLE, PUMP (72513-100-05) | 16 Mar, 2020 | N/A | No |
| 72513-100-06 | 59.14 mL in 1 BOTTLE, PUMP (72513-100-06) | 16 Mar, 2020 | N/A | No |
| 72513-100-07 | 29.57 mL in 1 BOTTLE, PUMP (72513-100-07) | 16 Mar, 2020 | N/A | No |
| 72513-100-08 | 3785.41 mL in 1 JUG (72513-100-08) | 16 Mar, 2020 | N/A | No |
| 72513-100-09 | 208198 mL in 1 DRUM (72513-100-09) | 28 Aug, 2018 | N/A | No |
| 72513-100-10 | 1040988.2406 mL in 1 TANK (72513-100-10) | 28 Aug, 2018 | N/A | No |
| 72513-100-11 | 1249185.88872 mL in 1 TANK (72513-100-11) | 28 Aug, 2018 | N/A | No |
| 72513-100-15 | 59 mL in 1 BOTTLE, PUMP (72513-100-15) | 28 Aug, 2018 | N/A | No |
| 72513-100-16 | 4 mL in 1 POUCH (72513-100-16) | 28 Aug, 2018 | N/A | No |
| 72513-100-17 | 4 mL in 1 POUCH (72513-100-17) | 28 Aug, 2018 | N/A | No |
| 72513-100-18 | 532.324 mL in 1 BOTTLE (72513-100-18) | 20 May, 2020 | N/A | No |
| 72513-100-19 | 1000 mL in 1 BAG (72513-100-19) | 28 Aug, 2018 | N/A | No |
| 72513-100-20 | 1000 mL in 1 BOTTLE (72513-100-20) | 20 May, 2020 | N/A | No |
| 72513-100-21 | 50 mL in 1 BOTTLE, PUMP (72513-100-21) | 28 Aug, 2018 | N/A | No |
| 72513-100-22 | 25 mL in 1 BOTTLE (72513-100-22) | 01 Mar, 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:
Purpose first aid antiseptic
Product Elements:
Microsure wound care benzalkonium chloride. hydrated silica water benzalkonium chloride benzalkonium
Indications and Usage:
Uses for first aid to help protect against infection in minor cuts, scrapes and burns. promotes healing of wounds. recommended for repeated use.
Warnings:
Warnings for external use only. doâ ânotâ âuseâ ââinâ âeyes or apply over large areas of the body.â consult a doctor in case of: deep puncture wounds ⢠animal bites ⢠serious burns.
Dosage and Administration:
Directions clean the affected area. pump a generous amount onto affected area 3 times daily, let dissipate into wound. allow to air dry before covering with sterile bandage.
Package Label Principal Display Panel:
First aid antiseptic advanced formula ⢠promotes healing of wounds (including diabetic wounds) ⢠guards against infection ⢠extended protection ⢠soothing treatment helps reduce bacteria that potentially cause disease. 25ml (0.85oz) 25ml 72513-100-22
Further Questions:
Questions? distributed by strategia 1000 jorie blvd. suite 370 oak brook, il 60523 visit microsure.com strategia toll free: 1-800-713-4055