NDC 63148-016 Kitchen Lemon Zest Antibacterial Foaming Hand

Benzalkonium Chloride

NDC Product Code 63148-016

NDC Code: 63148-016

Proprietary Name: Kitchen Lemon Zest Antibacterial Foaming Hand 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

  • 63148 - Apollo Health And Beauty Care Inc.
    • 63148-016 - Kitchen Lemon Zest Antibacterial Foaming Hand

NDC 63148-016-12

Package Description: 355 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Kitchen Lemon Zest Antibacterial Foaming Hand with NDC 63148-016 is a a human over the counter drug product labeled by Apollo Health And Beauty Care Inc.. The generic name of Kitchen Lemon Zest Antibacterial Foaming Hand is benzalkonium chloride. The product's dosage form is soap and is administered via topical form.

Labeler Name: Apollo Health And Beauty Care Inc.

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

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.

Kitchen Lemon Zest Antibacterial Foaming Hand 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)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) (UNII: X70SE62ZAR)
  • POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
  • SULISOBENZONE (UNII: 1W6L629B4K)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)

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: Apollo Health And Beauty Care Inc.
Labeler Code: 63148
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: 08-20-2019 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.

Kitchen Lemon Zest Antibacterial Foaming Hand Product Label Images

Kitchen Lemon Zest Antibacterial Foaming Hand 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 washing to decrease bacteria on the skin.

Warnings

For external use only.

When Using This Product

Avoid contact with eyes. In case of contact, rinse thoroughly with water.

Stop Use And Ask A Doctor If

Irritation ad redness develops and lasts.

Keep Out Of Reach Of Children.

In case of accidental ingestiong, get medical help or contact a Poison Control Center immediately.

Directions

  • Apply onto dry handslather and rinse thoroughly

Other Information

Store at room temperature

Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Glycerin, Hydroxyethylcellulose, Polyquaternium-7, Benzophenone-4, Tetrasodium EDTA, Fragrance (Parfum), Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5 (CI 19140), Red 40 (CI 16035).

* Please review the disclaimer below.