NDC 0363-1507 Walgreens Antiseptic Wound Wash

Benzethonium Chloride

NDC Product Code 0363-1507

NDC Code: 0363-1507

Proprietary Name: Walgreens Antiseptic Wound Wash Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Benzethonium Chloride Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 0363 - Walgreen Company
    • 0363-1507 - Walgreens Antiseptic Wound Wash

NDC 0363-1507-41

Package Description: 211 g in 1 BOTTLE

NDC Product Information

Walgreens Antiseptic Wound Wash with NDC 0363-1507 is a a human over the counter drug product labeled by Walgreen Company. The generic name of Walgreens Antiseptic Wound Wash is benzethonium chloride. The product's dosage form is solution and is administered via topical form.

Labeler Name: Walgreen Company

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Walgreens Antiseptic Wound Wash Active Ingredient(s)

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

  • BENZETHONIUM CHLORIDE 1.3 mg/g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Walgreen Company
Labeler Code: 0363
FDA Application Number: part333A Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 04-01-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Walgreens Antiseptic Wound Wash Product Label Images

Walgreens Antiseptic Wound Wash 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

Benzethonium Chloride 0.13%

Purpose

First aid Antiseptic

Uses

First aid to help prevent the risk of bacterial contamination in minor cuts, scrapes and burns.

Warnings

For external use only

Do Not Use

  • In the eyes or apply over large areas of the bodylonger than 1 week, unless directed by a doctorfor single patient use only

Ask A Doctor Before Use If You Have

Deep or puncture wounds, animal bites or serious burns

When Using This Product

  • Do not puncture or incineratecontents under pressure

Stop Use And Consult A Doctor If

  • Condition persists or gets worse

Directions

  • Clean the affected areaspray a small amount of this product on the area 1 to 3 times a daymay be covered with a sterile bandageif bandaged, let dry first

Other Information

  • Store between 59° and 86° F (15° and 30° C ).See bottom of can for lot # and expiration date

Inactive Ingredients

Aloe barbadensis leaf extract (aloe vera), benzalkonium chloride, maltodextrin, purified water, sodium bicarbonate, sodium chloride

Questions?

1-888-547-5492

* Please review the disclaimer below.

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