NDC 52000-047 Antibacterial Handwash Blueberries

Benzalkonium Chloride

NDC Product Code 52000-047

NDC 52000-047-01

Package Description: 400 mL in 1 BOTTLE

NDC Product Information

Antibacterial Handwash Blueberries with NDC 52000-047 is a a human over the counter drug product labeled by Universal Distribution Center Llc. The generic name of Antibacterial Handwash Blueberries is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Universal Distribution Center Llc

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.

Antibacterial Handwash Blueberries 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 .13 g/100mL

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)
  • SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
  • LAURETH-4 (UNII: 6HQ855798J)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SULISOBENZONE (UNII: 1W6L629B4K)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)

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: Universal Distribution Center Llc
Labeler Code: 52000
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: 03-25-2020 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.

Antibacterial Handwash Blueberries Product Label Images

Antibacterial Handwash Blueberries 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%

Otc - Purpose

PurposeAntibacterial

Indications & Usage

USESfor hand washing to decrease bacteria on the skin.

Warnings

Warning: Avoid contact with eyes. In case of contact flush with water. Keep out of direct sunlight. Do not drink, not edible. External use only.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Dosage & Administration

Directions: Pump a small amount of soap into wet hands, rub hands together to create rich lather, then rinse.

Inactive Ingredient

Ingredients: Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Betaine, Cocamide MIPA, Laureth-4, Glycerin*, Polyquaternium-7*, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium EDTA, Citric Acid, Benzophenono-4, Tocopheryl Acetate, FD&C Blue No. 1, D&C Red No. 33*Contains one or more of these ingredients.

Other

Kill Germs and OdorsDistributed By:Universal Distribution Center96 Distribution Boulevard,Edison, NJ 08817Made in Turkey

* Please review the disclaimer below.