NDC 43269-990 Antibacterial Wipes

Benzalkonium Chloride

NDC Product Code 43269-990

NDC 43269-990-60

Package Description: .1 mL in 1 POUCH

NDC Product Information

Antibacterial Wipes with NDC 43269-990 is a a human over the counter drug product labeled by Sj Creations, Inc.. The generic name of Antibacterial Wipes is benzalkonium chloride. The product's dosage form is swab and is administered via topical form.

Labeler Name: Sj Creations, Inc.

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab 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.

Antibacterial 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.

  • BENZALKONIUM CHLORIDE .1 mg/mL

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.

  • DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)

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: Sj Creations, Inc.
Labeler Code: 43269
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: 09-29-2020 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.

Antibacterial Wipes Product Label Images

Antibacterial 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 Ingredient(S)

Benzalkonium Chloride 0.1% v/v. Purpose: Antiseptic

Purpose

Antibacterial, Wipe

Use

Hand sanitizer to help reduce bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from fire and flame

Otc - When Using

When using this product avoid contact with eyes. In case of contact, rinse eyes thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if irritation and redness develop.

Otc - Keep Out Of Reach Of Children

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

Directions

  • Wet hands thoroughly with product and allow to dryChildren under 6 years of age should be supervised when using this product.

Other Information

  • Store at 20-25C (68-77F)May discolor some fabrics or surfaces

Inactive Ingredients

Water (Aqua), Ethyl Alcohol, Glycerin, Propylene Glycol, Phenoxyethanol, Didecyldimethylammonium Chloride, Exylhexylglycerin, Fragrance (Parfum).

* Please review the disclaimer below.