NDC 71315-900 Zudz Hand Sanitizer

Benzalkonium Chloride

NDC Product Code 71315-900

NDC 71315-900-19

Package Description: 18900 g in 1 DRUM

NDC 71315-900-38

Package Description: 3780 g in 1 JUG

NDC 71315-900-99

Package Description: 1000 g in 1 BOTTLE

NDC Product Information

Zudz Hand Sanitizer with NDC 71315-900 is a a human over the counter drug product labeled by Katan Tech / Quality Blending. The generic name of Zudz Hand Sanitizer is benzalkonium chloride. The product's dosage form is spray and is administered via topical form.

Labeler Name: Katan Tech / Quality Blending

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.

Zudz Hand Sanitizer 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.

  • DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)
  • 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.
  • 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: Katan Tech / Quality Blending
Labeler Code: 71315
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: 10-01-2020 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.

Zudz Hand Sanitizer 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 ingredients PurposeBenzalkonium Chloride 0.13%........................ Antimicrobial

Otc - Purpose

Uses• For hand sanitizing to decrease bacteria on the skin • Recommended for repeated use

Indications & Usage

Uses• For hand sanitizing to decrease bacteria on the skin • Recommended for repeated use

Warnings And Precautions

Warnings

For external use only

Warnings

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Otc - When Using

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water

Otc - Stop Use

Stop use and ask a doctor if irritation or redness develops, or it conditions persists for more than 72 hours

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

Apply small quantity to hands. Rub thoroughly to cover hands and fingers.

Instructions For Use

Directions• Pump a small amount into palm of hand

• Rub thoroughly over all surfaces of both hands • Rub hand together briskly until dry

Inactive Ingredient

Inactive IngredientsWater, Polysilsesquioxane Steardimonium Chloride

Contact:

Vanalay

6812 Hemlock Lane
Maple Grove,MN 55369Vanalay.com

Drug Facts

Active ingredients PurposeBenzalkonium Chloride 0.13%........................ Antimicrobial

* Please review the disclaimer below.