NDC 78411-002 Defender Wipe

Benzalkonium Chloride

NDC Product Code 78411-002

NDC 78411-002-01

Package Description: 10 POUCH in 1 BAG > .005265 g in 1 POUCH

NDC 78411-002-02

Package Description: 900 POUCH in 1 BAG > 4.7385 g in 1 POUCH

NDC 78411-002-03

Package Description: 1200 POUCH in 1 BAG > 6.318 g in 1 POUCH

NDC 78411-002-04

Package Description: 180 POUCH in 1 BAG > .09477 g in 1 POUCH

NDC 78411-002-05

Package Description: 250 POUCH in 1 BAG > .131625 g in 1 POUCH

NDC 78411-002-06

Package Description: 80 POUCH in 1 BAG > .04212 g in 1 POUCH

NDC 78411-002-07

Package Description: 800 POUCH in 1 BAG > .4212 g in 1 POUCH

NDC 78411-002-08

Package Description: 180 POUCH in 1 PAIL > .09477 g in 1 POUCH

NDC 78411-002-09

Package Description: 250 POUCH in 1 PAIL > 1.31625 g in 1 POUCH

NDC 78411-002-10

Package Description: 20 POUCH in 1 BAG > .01053 g in 1 POUCH

NDC Product Information

Defender Wipe with NDC 78411-002 is a a human over the counter drug product labeled by Zhejiang Qirun Daily Necessities Co., Ltd.. The generic name of Defender Wipe is benzalkonium chloride. The product's dosage form is swab and is administered via topical form.

Labeler Name: Zhejiang Qirun Daily Necessities Co., Ltd.

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.

Defender Wipe 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/100g

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)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: Zhejiang Qirun Daily Necessities Co., Ltd.
Labeler Code: 78411
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: 05-30-2020 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.

Defender Wipe Product Label Images

Defender Wipe 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

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Use

For hand sanitizing to decrease bacteria on the skin.

Warning

For external use onlyMay irritate eyes Keep out reach of children unless under adult supervision

Otc - Keep Out Of Reach Of Children

Keep out of reach of children unless under adult supervision

Directions

Tear V notch located on top of the plastic bag.

Pull out the first wipe approoirmately 6 to 8 inches from the center of the rol.

Place entire bag inside of center pull dispenser,

Thread the wipe through the opening on the dispenser,

Closo the id of the disponser. Wipe dispensing tension may be adjusted on tho top of

dispenser. Dispenser must be mounted with wipes desponsing up.

Apply topically to the skin to help prevent cross contamination.

Recommended for repeated use.

Dries in seconds.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Aqua,Parfum, Phenoxyethanol, Propylene Glycol, Polysorbate 20,Tocopheryl Acetate

* Please review the disclaimer below.