NDC 47682-333 Green Guard Antiseptic

Benzalkonium Chloride

NDC Product Code 47682-333

NDC 47682-333-02

Package Description: .0591 L in 1 BOTTLE, SPRAY

NDC Product Information

Green Guard Antiseptic with NDC 47682-333 is a a human over the counter drug product labeled by Unifirst First Aid Corporation. The generic name of Green Guard Antiseptic is benzalkonium chloride. The product's dosage form is spray and is administered via topical form.

Labeler Name: Unifirst First Aid Corporation

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.

Green Guard Antiseptic 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 1.3 g/L

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)
  • 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: Unifirst First Aid Corporation
Labeler Code: 47682
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: 03-01-2021 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 - 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Green Guard Antiseptic 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

Otc - Active Ingredient

Active ingredientBenzalkonium Chloride 0.13%

Otc - Purpose

PurposeFirst aid antiseptic

Indications & Usage

UsesFirst aid to help prevent infection in minor cuts, scrapes and burns

Warnings

WarningsFor external use only.Flammable keep away from tire or flame

Otc - Do Not Use

  • Do not usenear eyes or mucous membraneson deep or puncture wounds, animal bites, or serious burnsover large areas of the bodymore than one week unless directed by a doctor

Otc - Stop Use

Stop use and ask a doctor if condition persists or gets worse

Otc - 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.

Dosage & Administration

  • Directionsclean affected area & spray 1 to 3 times dailymay be covered with a sterile bandagenot to be used on children under 12 years of age

Inactive Ingredient

Inactive ingredientsethyl alcohol, purified water

Otc - Questions

Questions or comments? 1-800-869-6970

Green Gurad Antiseptic Spray Label

Antiseptic sprayBenzalkonium Chloride 0.13%First Aid AntisepticTreats minor cuts, scrapes and abrasion

Helps prevent infection
Store at 68°-77°F (20°-25°C)Green Guard2 fl oz (59.1mL)

* Please review the disclaimer below.