NDC 72513-100 Microsure Wound Care

Benzalkonium Chloride.

NDC Product Code 72513-100

NDC 72513-100-01

Package Description: 50 mL in 1 BOTTLE, PUMP

NDC 72513-100-02

Package Description: 125 mL in 1 BOTTLE, PUMP

NDC 72513-100-03

Package Description: 250 mL in 1 BOTTLE, PUMP

NDC 72513-100-04

Package Description: 59.14 mL in 1 BOTTLE, PUMP

NDC 72513-100-05

Package Description: 59.14 mL in 1 BOTTLE, PUMP

NDC 72513-100-06

Package Description: 59.14 mL in 1 BOTTLE, PUMP

NDC 72513-100-07

Package Description: 29.57 mL in 1 BOTTLE, PUMP

NDC 72513-100-08

Package Description: 3785.41 mL in 1 JUG

NDC 72513-100-09

Package Description: 208198 mL in 1 DRUM

NDC 72513-100-10

Package Description: 1040988.2406 mL in 1 TANK

NDC 72513-100-11

Package Description: 1249185.88872 mL in 1 TANK

NDC 72513-100-15

Package Description: 59 mL in 1 BOTTLE, PUMP

NDC 72513-100-16

Package Description: 4 mL in 1 POUCH

NDC 72513-100-17

Package Description: 4 mL in 1 POUCH

NDC 72513-100-18

Package Description: 532.324 mL in 1 BOTTLE

NDC 72513-100-19

Package Description: 1000 mL in 1 BAG

NDC 72513-100-20

Package Description: 1000 mL in 1 BOTTLE

NDC 72513-100-21

Package Description: 50 mL in 1 BOTTLE, PUMP

NDC 72513-100-22

Package Description: 25 mL in 1 BOTTLE

NDC Product Information

Microsure Wound Care with NDC 72513-100 is a a human over the counter drug product labeled by Strategia Project Management, Inc.. The generic name of Microsure Wound Care is benzalkonium chloride.. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Strategia Project Management, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Microsure Wound Care Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BENZALKONIUM CHLORIDE .13 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Strategia Project Management, Inc.
Labeler Code: 72513
FDA Application Number: part333A What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 08-28-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Microsure Wound Care Product Label Images

Microsure Wound Care Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Benzalkonium Chloride.... 0.13%

Purpose

First Aid Antiseptic

Uses

For first aid to help prevent infection in minor cuts, scrapes & burns

Warnings

  • For external use only. Do not use in the eyes, or apply over large areas of the body. Consult a doctor in case of:deep puncture woundsanimal bitesserious burns

Stop Use And Ask A Doctor

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

Inactive Ingredients

Water, Hydrated Silica Complex

Questions?

Distributed by Strategia1000 Jorie Blvd. Suite 370Oakbrook, IL 60523Online at Microsure.comStrategia Toll Free:866-37-STRAT866-377-8726

First Aid Antiseptic

Gentle Foam FormulaPromote HealingGuard Against InfectionExtend ProtectionNo Sting FormulaKills 99.99% of GermsShari'ah Compliant50 mL (1.7 oz)

* Please review the disclaimer below.