NDC 69560-012 Berkley Jensen Dishwashing And Antibacterial Hand Green Apple Scent

Chloroxylenol

NDC Product Code 69560-012

NDC CODE: 69560-012

Proprietary Name: Berkley Jensen Dishwashing And Antibacterial Hand Green Apple Scent 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: Chloroxylenol 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):
GREEN (C48329)

NDC Code Structure

  • 69560 - Mid-continent Packaging, Inc.
    • 69560-012 - Berkley Jensen Dishwashing And Antibacterial Hand

NDC 69560-012-04

Package Description: 2950 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Berkley Jensen Dishwashing And Antibacterial Hand Green Apple Scent with NDC 69560-012 is a a human over the counter drug product labeled by Mid-continent Packaging, Inc.. The generic name of Berkley Jensen Dishwashing And Antibacterial Hand Green Apple Scent is chloroxylenol. The product's dosage form is solution and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 413261.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Berkley Jensen Dishwashing And Antibacterial Hand Green Apple Scent 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)
  • SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
  • SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • ALCOHOL (UNII: 3K9958V90M)
  • SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • BENZISOTHIAZOLINONE (UNII: HRA0F1A4R3)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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: Mid-continent Packaging, Inc.
Labeler Code: 69560
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: 07-01-2021 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".

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Berkley Jensen Dishwashing And Antibacterial Hand Green Apple Scent Product Label Images

Berkley Jensen Dishwashing And Antibacterial Hand Green Apple Scent 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

Other

Drug Facts

Distributed by: BJ's Wholesale Club25 Research Drive, Westborough, MA 01581

Active Ingredient

Choroxylenol 0.30%

Purpose

Antibacterial hand soap

Use

For handwashing to decrease bacteria on the skin

Warnings

For external use only

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental Ingestion, drink a glass of water to dilute. If eye contact occurs, rinse thoroughly with water.

Directions

Wet hands and forearms. Apply 5 ml or palmful to hands and forearms. Scrub thoroughly for 30 sec. and rinse.

Inactive Ingredients

Water, Sodium Laureth Sulfate, Sodium Dodecylbenzenesulfon-ate, Sodium Chloride, Alcohol Denat., Sodium Xylenesulfonate, Sodium Lauryl Sulfate, Tetrasodium EDTA, Benzisothiazolinone, Methylisothiazolinone, Methylchloroisothiazolinone, Fragrance, FD&C Yellow No. 5, FD&C Blue No. 1

Questions?

1-800-934-1204

* Please review the disclaimer below.