NDC 0363-0589 First Aid Antiseptic Wipes

Benzalkonium Chloride (0.13%)

NDC Product Code 0363-0589

NDC 0363-0589-01

Package Description: 20 PACKET in 1 CARTON > 1 mg in 1 PACKET

NDC Product Information

First Aid Antiseptic Wipes with NDC 0363-0589 is a a human over the counter drug product labeled by Walgreen Co. The generic name of First Aid Antiseptic Wipes is benzalkonium chloride (0.13%). The product's dosage form is cloth and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1038558.

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

First Aid Antiseptic Wipes 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.


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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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: Walgreen Co
Labeler Code: 0363
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: 02-08-2017 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".

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First Aid Antiseptic Wipes Product Label Images

First Aid Antiseptic Wipes 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

Benalkonium chloride (0.13%)

Purpose

First Aid Antiseptic

Use

First aid to help prevent the rist of infection in minor cuts, scrapes, and burns

Warnings

For external use only

Do Not Use

In the eyes or apply over large areas of the body.In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Stop Use And Ask A Doctor If

The condition persists or gets worse.  Do not use longer than 1 week unless directed by a doctor.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contqact a Poison Control Center right away

Directions:

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

Inactive Ingredients

Water, glycerin, sodium cocoamphoacetate,  Aloe barbadensis leaf juice, tocopheryl acetate, fragrance, polysorbate 20, tetrasodium EDTA, phenoxyethanol, methylparaben, ethylparaben, potassium sorbate, sodium benzoate, sodium hydroxide, citric acid

Adverse Reactions

Walgreens Pharmacist Survey Study, November 2014Questions or comments? 1-800-925-4733DISTRIBUTED BY: WALGREEN CO.200 WILMOT RD., DEERFIELD, IL 60015100% SATISFACTION GUARANTEEDwalgreens.com  2016 Walgreen Co.MADE IN ISRAEL

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