NDC 64092-348 Hand Wash Lemon

Benzalkonium Chloride

NDC Product Code 64092-348

NDC CODE: 64092-348

Proprietary Name: Hand Wash Lemon 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.

Product Characteristics

Color(s):
RED (C48326 - CLEAR)
WHITE (C48325 - CLEAR)
YELLOW (C48330)
YELLOW (C48330 - CLEAR)

NDC Code Structure

  • 64092 - Great Lakes Wholesale, Marketing, And Sales, Inc

NDC 64092-348-07

Package Description: 222 mL in 1 BOTTLE, PUMP

NDC Product Information

Hand Wash Lemon with NDC 64092-348 is a a human over the counter drug product labeled by Great Lakes Wholesale, Marketing, And Sales, Inc. The generic name of Hand Wash Lemon is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1233282.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Hand Wash Lemon 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)
  • WATER (UNII: 059QF0KO0R)
  • WATER (UNII: 059QF0KO0R)
  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Great Lakes Wholesale, Marketing, And Sales, Inc
Labeler Code: 64092
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: 06-30-2016 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 - 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.

Hand Wash Lemon Product Label Images

Hand Wash Lemon 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

Description

GLS PERSONAL CARE SOLUTIONSAntibacterial Foaming Hand SoapKills 99.99% of GermsLeaves Skin Feeling Soft & SmoothEnriched with Moisturizers 7.5 fl oz (222mL)

Otc - Active Ingredient

Active Ingredient PurposeBenzalkonium Chloride 0.10% ...........................Antibacterial

Otc - Purpose

Hand Soap

Indications & Usage

Decrease bacteria on the skin.

Warnings

For external use onlyAvoid eye contact. If contact occurs rinse thoroughly with water.

Instructions For Use

Pump foam into hands, lather vigorously and rinse.

Dosage & Administration

Antibacterial Foaming Hand Soap0.10% Benzalkonium Chloride

Inactive Ingredient

Water (Aqua), Sodium Laureth Sulfate, Dipropylene Glycol, Glycerin, Sodium PCA, Ammonium Lauryl Sulfate, Cocamidopropyl Betaine, Polyquatemium 10, Fragrance, Disodium Phosphate, Citric Acid, FD&C Yellow No. 5.

* Please review the disclaimer below.