NDC 44385-7012 Wet-nap Antibacterial Hand Wipes Citrus

Antibacterial Hand Wipes

NDC Product Code 44385-7012

NDC Code: 44385-7012

Proprietary Name: Wet-nap Antibacterial Hand Wipes Citrus 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: Antibacterial 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

  • 44385 - Nice-pak Products Inc
    • 44385-7012 - Wet-nap Antibacterial Hand Wipes Citrus

NDC 44385-7012-1

Package Description: 193.1 mL in 1 CANISTER

NDC 44385-7012-2

Package Description: 24 PACKET in 1 BOX > 4.4 mL in 1 PACKET

NDC 44385-7012-3

Package Description: 20 APPLICATOR in 1 CELLO PACK > 2.6 mL in 1 APPLICATOR

NDC 44385-7012-4

Package Description: 30 PACKET in 1 BOX > 4.4 mL in 1 PACKET

NDC 44385-7012-5

Package Description: 266 mL in 1 CANISTER

NDC Product Information

Wet-nap Antibacterial Hand Wipes Citrus with NDC 44385-7012 is a a human over the counter drug product labeled by Nice-pak Products Inc. The generic name of Wet-nap Antibacterial Hand Wipes Citrus is antibacterial hand wipes. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Nice-pak Products 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.

Wet-nap Antibacterial Hand Wipes Citrus 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/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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • SORBIC ACID (UNII: X045WJ989B)
  • PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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: 03-28-2019 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: 12-31-2020 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.

Wet-nap Antibacterial Hand Wipes Citrus 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

PurposeAntiseptic handwash

Indications & Usage

UseFor handwashing to decrease bacteria on the skin

Warnings

WarningsFor external use only

Otc - Keep Out Of Reach Of Children

Keep out of reach of childrenIf swallowed, get medical help or contact a Poison Control Center right away

Otc - Do Not Use

Do not use in the eyesDiscontinue use if irritation and redness develop.If condition persists for more than 72 hours consult a doctor.

Dosage & Administration

DirectionsTo dispense, lift cover, remove seal, pull center sheet from roll, twist to a point, feed through dispenser hole in cover.Keep lid closed to prevent moisture loss.Use as a part of your hand cleansing routine.Rub product onto hands and allow to dry.Discard after single use.

References

Other informationLot No. and Expiration Date can be found on canister.

Inactive Ingredient

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

* Please review the disclaimer below.

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