NDC 74177-850 Ultra Defense Sani Smart Hand Sanitizing Wipes

Benzalkonium Chloride

NDC Product Code 74177-850

NDC CODE: 74177-850

Proprietary Name: Ultra Defense Sani Smart Hand Sanitizing Wipes What 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: Benzalkonium Chloride What 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.

NDC Code Structure

  • 74177 - K7 Design Group Inc.
    • 74177-850 - Ultra Defense Sani Smart Hand Sanitizing Wipes

NDC 74177-850-70

Package Description: 70 CANISTER in 1 CANISTER > 191 g in 1 CANISTER

NDC Product Information

Ultra Defense Sani Smart Hand Sanitizing Wipes with NDC 74177-850 is a a human over the counter drug product labeled by K7 Design Group Inc.. The generic name of Ultra Defense Sani Smart Hand Sanitizing Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: K7 Design Group Inc.

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.

Ultra Defense Sani Smart Hand Sanitizing 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 1.3 mg/g

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.

  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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: K7 Design Group Inc.
Labeler Code: 74177
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: 08-25-2020 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.

Ultra Defense Sani Smart Hand Sanitizing Wipes Product Label Images

Ultra Defense Sani Smart Hand Sanitizing 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

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

  • For hand sanitizing to decrease bactera on the skin.Apply topically to the skin to help prevent cross contamination.Recommended for repeated use.Dries in seconds.

Warnings

For external use only.

When Using This Product

Do not use in or contact the eyes.

Stop Use And Ask A Doctor If

Too much skin irritation or sensitivity develops or increases.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • Remove lid and discard seal from container.Pull wipe from center of roll and thread through opening in lid.Do not push finger through opening.Replace lid, pull wipe up, and then out at a 45º angle. The next wipe dispenses automatically.Close lid to retain moisture.

Other Information

  • Lot No. Manufacture date and Expiration date can be found on canister.

Inactive Ingredients

Water, Phenoxyethanol, Ethyl Alcohol, DMDM Hydantoin, Glycerin, Propylene Glycol, Cocamidopropyl Betaine, Decyl glucoside, Aloe Barbadensis Leaf Extract

Company Information

YOU MAY REPORT A SERIOUS ADVERSE REACTION TO THIS PRODUCT TO REPORT REACTION, LLC, PO BOX 22, PLAINSBORO, NJ 08536MANUFACTURED FOR & DISTRIBUTED BY K7 DESIGN GROUP INC. 2433 KNAPP STREET, BROOKLYN, NY 11235

Product Packaging - 70 Count

ULTRA DEFENSESANI+SMARTHANDSANITIZINGWIPES70 COUNTCOTTON SOFT WIPESKILLS 99.99% OF GERMS5.71 in x 8.07 in (14.5cm x 20.5cm)

* Please review the disclaimer below.