NDC 75054-093 Covaguard Mask

Antimicrobial Sanitizer With Benzalkonium Chloride

NDC Product Code 75054-093

NDC 75054-093-01

Package Description: 100 mL in 1 BOTTLE, SPRAY

NDC 75054-093-02

Package Description: 237 mL in 1 BOTTLE, SPRAY

NDC 75054-093-03

Package Description: 250 mL in 1 BOTTLE, SPRAY

NDC 75054-093-04

Package Description: 30 mL in 1 BOTTLE, SPRAY

NDC 75054-093-05

Package Description: 710 mL in 1 BOTTLE, SPRAY

NDC 75054-093-06

Package Description: 60 mL in 1 BOTTLE, SPRAY

NDC Product Information

Covaguard Mask with NDC 75054-093 is a a human over the counter drug product labeled by Covalon Technologies Ltd.. The generic name of Covaguard Mask is antimicrobial sanitizer with benzalkonium chloride. The product's dosage form is spray and is administered via topical form.

Labeler Name: Covalon Technologies Ltd.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Covaguard Mask 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.

  • ALCOHOL (UNII: 3K9958V90M)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • MYRISTYL ALCOHOL (UNII: V42034O9PU)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • CITRUS SINENSIS LEAF (UNII: VF01D90MZI)

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.
  • 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: Covalon Technologies Ltd.
Labeler Code: 75054
FDA Application Number: part333E 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: 04-30-2020 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Covaguard Mask 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

Covaguard Mask - Antimicrobial Sanitizer With Benzalkonium Chloride

Benzalkonium Chloride 0.13% w/w

Otc - Purpose

Antimicrobial Sanitizer

Warnings

For external use only.When using this product, avoid contact with eyes. If it comes in contact with eyes, rinse thoroughly with water.Stop using and consult a healthcare practitioner if irritation develops.Keep out of reach of children.If swallowed, call a poison control center or get medical help right away.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Instructions For Use

For up to 24h of increased protection against a wide range of microbes, fungi and viruses: Spray liberally and allow to dry.

Storage And Handling

Store between 15°C/59°F to 30°C/86°F.

Inactive Ingredient

Ethanol, Soy Phosphatidylcholine, Myristyl Alcohol, Didecyldimethylammonium Chloride, Orange Essential Oil, Sodium Bicarbonate, Disodium EDTA

Otc - Questions

1-877-711-6055

Dosage & Administration

Spray liberally and allow to dry.

Indications & Usage

Antiseptic Sanitizer and Hand Rub.

* Please review the disclaimer below.