NDC 44385-7014 Nice N Clean Wipes Sani-hands Antimicrobial Hand Wipes

Benzalkonium Chloride Hand Wipes

NDC Product Code 44385-7014

NDC CODE: 44385-7014

Proprietary Name: Nice N Clean Wipes Sani-hands Antimicrobial Hand 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 Hand Wipes 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

NDC 44385-7014-1

Package Description: 53 mL in 1 CELLO PACK

NDC 44385-7014-2

Package Description: 175 mL in 1 CELLO PACK

NDC 44385-7014-3

Package Description: 4 CELLO PACK in 1 BOX > 53 mL in 1 CELLO PACK (44385-7014-1)

NDC 44385-7014-4

Package Description: 261 mL in 1 CELLO PACK

NDC 44385-7014-5

Package Description: 6 CELLO PACK in 1 TRAY > 53 mL in 1 CELLO PACK (44385-7014-1)

NDC 44385-7014-6

Package Description: 16 CELLO PACK in 1 BOX > 53 mL in 1 CELLO PACK (44385-7014-1)

NDC Product Information

Nice N Clean Wipes Sani-hands Antimicrobial Hand Wipes with NDC 44385-7014 is a a human over the counter drug product labeled by Nice-pak Products, Inc.. The generic name of Nice N Clean Wipes Sani-hands Antimicrobial Hand Wipes is benzalkonium chloride hand wipes. The product's dosage form is swab and is administered via topical form.

Labeler Name: Nice-pak Products, 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.

Nice N Clean Wipes Sani-hands Antimicrobial Hand 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)
  • ALCOHOL (UNII: 3K9958V90M)

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: Nice-pak Products, Inc.
Labeler Code: 44385
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: 12-20-2020 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.

Nice N Clean Wipes Sani-hands Antimicrobial Hand 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

Otc - Active Ingredient

Active ingredientBenzalkonium Chloride 0.13%w/w

Otc - Purpose


Indications & Usage

UseTo decrease bacteria on the skin


WarningsFor external use only.Flammable, keep away from fire or flameWhen using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.Stop use and ask a doctor if irritation or redness develolps and contines for more than 72 hours.Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away..

Dosage & Administration

DirectionsPull back label slowly.Pull out wipe and reseal label.Unfold and use, discarding after single use.Wet hands thoroughly with product and allow to dry without wiping..

Inactive Ingredient

Inactive ingredientsWater, SD Alcohol 40-B, Sorbic Acid, PPG-2 Hydroxyethyl Cocamide, Disodium EDTA, Aloe Barbadensis Leaf Juice, Fragrance


Other information:For more information, please visit www.nicencleanwipes.com

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medicalhelp or contact a Poison Control Center right away.

* Please review the disclaimer below.