NDC 58575-511 Antibacterial

Chloroxylenol

NDC Product Code 58575-511

NDC 58575-511-01

Package Description: 1000 mL in 1 BAG

NDC 58575-511-02

Package Description: 6000 mL in 1 CASE

NDC Product Information

Antibacterial with NDC 58575-511 is a a human over the counter drug product labeled by Inopak, Ltd. The generic name of Antibacterial is chloroxylenol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Inopak, Ltd

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 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 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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • COCAMIDE (UNII: 3YXD33R71G)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • ALCOHOL (UNII: 3K9958V90M)
  • FD&C RED NO. 4 (UNII: X3W0AM1JLX)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • 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: Inopak, Ltd
Labeler Code: 58575
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: 01-01-2018 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.

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

Active Ingredient

Parachlorometaxylenol 0.3%

Purpose

Antibacterial

Use

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

Warnings

  • For external use onlyKeep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.Stop use and ask a doctor if irritation or redness develop or if condition persists for more than 72 hours.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

When Using

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

Stop Use

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

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.

Directions

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

Inactive Ingredient

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

Puresan Individual Label

  • Avro-218AntibacterialFoaming 0.3% PCMXHand Wash1000 mLRefill Bag FOAMItem# 218                                            puresanMADE                                                   cleaning innovationsIN THE USADrug FactsActive Ingredient                                         PurposeParachlorometaxylenol 0.3% w/w           AntisepticUsesHandwash to help reduce bacteria on the skin that potentially can cause disease.Recommended for repeated use.WarningsFor external use onlyKeep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.Stop use and ask a doctor if irritation or redness develop or if condition persists for more than 72 hours.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.DirectionsWet hands with water and dispense sufficient amount of product into cupped palm of hand.Wash both hands thoroughly for 15 minutes.Rinse under running water and dry thoroughly.Inactive ingredients: Citric acid, Cocamide DEA, DMDM Hydantoin, Fragrance, Ethyl Alcohol, FD&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water.Rev. 1.1PO Box 170, Sparta NJ 07871855.500.8080 • puresanusa.com

Puresan Case Label

  • Puresan                                                                              puresanusa.com              cleaning innovations                                                      (855) 500-8080ITEM # 218PURESAN Antibacterial 1000ml Foam SoapRefill Bag Case of 6                                                           37654 69790QTY 61000ml refills per caseAVRO-218-CS                                                                                    Avro-218AntibacterialFoaming 0.3% PCMXHand Wash1000 mLRefill Bag FOAMItem# 218                                            puresanMADE                                                   cleaning innovationsIN THE USADrug FactsActive Ingredient                                         PurposeParachlorometaxylenol 0.3% w/w           AntisepticUsesHandwash to help reduce bacteria on the skin that potentially can cause disease.Recommended for repeated use.WarningsFor external use onlyKeep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.Stop use and ask a doctor if irritation or redness develop or if condition persists for more than 72 hours.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.DirectionsWet hands with water and dispense sufficient amount of product into cupped palm of hand.Wash both hands thoroughly for 15 minutes.Rinse under running water and dry thoroughly.Inactive ingredients: Citric acid, Cocamide DEA, DMDM Hydantoin, Fragrance, Ethyl Alcohol, FD&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water.Rev. 1.1PO Box 170, Sparta NJ 07871855.500.8080 • puresanusa.com

* Please review the disclaimer below.