NDC 80586-513 Greenex Antibacterial

Chloroxylenol

NDC Product Code 80586-513

NDC 80586-513-10

Package Description: 1000 mL in 1 CARTRIDGE

NDC Product Information

Greenex Antibacterial with NDC 80586-513 is a a human over the counter drug product labeled by Cleanslate Group Llc. The generic name of Greenex Antibacterial is chloroxylenol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Cleanslate Group 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.

Greenex Antibacterial 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.

  • CHLOROXYLENOL .3 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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • COCO DIETHANOLAMIDE (UNII: 92005F972D)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • ALCOHOL (UNII: 3K9958V90M)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • FD&C RED NO. 4 (UNII: X3W0AM1JLX)
  • SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
  • 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: Cleanslate Group Llc
Labeler Code: 80586
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: 04-13-2021 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".

* Please review the disclaimer below.

Greenex Antibacterial Product Label Images

Greenex Antibacterial 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

GREENEX2 Bergen TurnpikeRidgefield Park, NJ 07660MADE IN THE USA

Otc - Active Ingredient

Active IngredientParachlorometaxylenol 0.3% w/w

Otc - Purpose

PurposeAntiseptic

Indications & Usage

  • UsesHandwash to help reduce bacteria on the skin that potentially can cause disease.Recommended for repeated use.

Warnings

  • WarningsFor external use only.

Otc - When Using

  • Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.

Otc - Stop Use

  • Stop use and ask a doctor if irritation or redness develop or if condition persists for more than 72 hours.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • DirectionsWet hands with water and dispense sufficient amount of product into cupped palm of hand.Wash both hands thoroughly for 15 seconds.Rinse under running water and dry thoroughly.

Inactive Ingredient

Inactive IngredientsCitric acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, FD&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water.

* Please review the disclaimer below.