NDC 44385-7022 Nice N Clean Wipes Sani-hands Sanitizing Hand Wipes 70 Percent Alcohol

Alcohol

NDC Product Code 44385-7022

NDC CODE: 44385-7022

Proprietary Name: Nice N Clean Wipes Sani-hands Sanitizing Hand Wipes 70 Percent Alcohol 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: Alcohol 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

  • 44385 - Nice-pak Products, Inc.

NDC 44385-7022-1

Package Description: 3.51 mL in 1 PACKET

NDC 44385-7022-2

Package Description: 24 PACKET in 1 BOX > 3.51 mL in 1 PACKET (44385-7022-1)

NDC Product Information

Nice N Clean Wipes Sani-hands Sanitizing Hand Wipes 70 Percent Alcohol with NDC 44385-7022 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 Sanitizing Hand Wipes 70 Percent Alcohol is alcohol. 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 Sanitizing Hand Wipes 70 Percent Alcohol 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.

  • ALCOHOL .7 mL/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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • 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.

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: part333E 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: 03-22-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Nice N Clean Wipes Sani-hands Sanitizing Hand Wipes 70 Percent Alcohol Product Label Images

Nice N Clean Wipes Sani-hands Sanitizing Hand Wipes 70 Percent Alcohol 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

Ethanol 70% by volume

Otc - Purpose

Antiseptic

Indications & Usage

To decrease bacteria on the skin

Warnings

WarningsFlammable. Keep away from fire or flame.For external use only.When 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 develops and continues for more than 72 hours.

Dosage & Administration

DirectionsTear open packet.Open and unfold wipe.Thoroughly wipe hands, fingers and wrists using entire wipe.Allow to dry.For dirty hands, use first wipe to clean hands, then discard wipe; sanitize with second wipeDiscard after single use.

Inactive Ingredient

Water, Propylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate

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.

* Please review the disclaimer below.