Choice Liquid Antibacterial
Parachlorometaxylenol
Inopak, Ltd.
Human Otc Drug
NDC 58575-407Choice Liquid Antibacterial also known as Parachlorometaxylenol is a human otc drug labeled by 'Inopak, Ltd.'. National Drug Code (NDC) number for Choice Liquid Antibacterial is 58575-407. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Choice Liquid Antibacterial drug includes Chloroxylenol - .3 mg/mL . The currest status of Choice Liquid Antibacterial drug is Active.
Drug Information:
| Drug NDC: | 58575-407 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Choice Liquid Antibacterial |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Parachlorometaxylenol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Inopak, Ltd. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CHLOROXYLENOL - .3 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Jan, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 28 Jul, 2024 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part333A |
| 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. |
| Listing Expiration Date: | 09 May, 2026 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | |
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 58575-407-01 | 3785 mL in 1 CONTAINER (58575-407-01) | 01 Jan, 2018 | 22 Jul, 2024 | No |
| 58575-407-02 | 800 mL in 1 CONTAINER (58575-407-02) | 01 Jan, 2018 | 28 Jul, 2024 | No |
| 58575-407-03 | 9600 mL in 1 CASE (58575-407-03) | 01 Jan, 2018 | 28 Jul, 2024 | No |
| 58575-407-04 | 15140 mL in 1 CASE (58575-407-04) | 01 Jan, 2018 | 22 Jul, 2024 | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose antiseptic
Product Elements:
Choice liquid antibacterial parachlorometaxylenol citric acid acetate cocamidopropyl dimethylamine dmdm hydantoin alcohol fd&c red no. 4 fd&c yellow no. 5 isopropyl alcohol sodium chloride sodium laureth sulfate water chloroxylenol chloroxylenol
Indications and Usage:
Uses ⢠handwash to help reduce bacteria on the skin that potentially can cause disease. ⢠recommended for repeated use.
Warnings:
Warnings ⢠for external use only. ⢠keep out of eyes, ears, or mouth. in case of eye contact, flush eyes with water. ⢠keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using keep out of eyes, ears, or mouth. in case of eye contact, flush eyes with water.
Dosage and Administration:
Directions ⢠wet 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.
Stop Use:
Stop using if swallowed, get medical help or contact a poison control center right away.
Package Label Principal Display Panel:
Choice liquid antibacterial soap single label rev. 1.01 broad spectrum germ control contains .3% p.c.m.x choice liquid antibacterial soap with moisturizers drug facts active ingredient purpose parachlorometaxylenol 0.3% w/wâ¦. antiseptic uses ⢠handwash to help reduce bacteria on the skin that potentially can cause disease. ⢠recommended for repeated use. warnings ⢠for external use only. ⢠keep out of eyes, ears, or mouth. in case of eye contact, flush eyes with water. ⢠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 seconds. ⢠rinse under running water and dry thoroughly. inactive ingredients citric acid, cocamide dea, d&c red 4, dmom hydantoin, ethyl alcohol, fd&c yellow 5, fragrance, isopropyl alcohol, sodium chloride, sodium laureth sulfate, water. questions? call 1-800-767-7725 or visit our website www.inopack.com choice single label
Choice case label broad spectrum germ control contains .3% p.c.m.x choice liquid antibacterial soap with moisturizers o 12/800 ml uv 5031-404uv-ch 0 40232 65079 6 o 4/1 gallon 5031-420-02ch 0 40232 65069 7 made in the usa 5031-ch-cs rev. 1.0 choice case label
Choice box front label 401-1-80 drug facts active ingredient purpose parachlorometaxylenol 0.3% w/wâ¦. antiseptic uses ⢠handwash to help reduce bacteria on the skin that potentially can cause disease. ⢠recommended for repeated use. warnings ⢠for external use only. ⢠keep out of eyes, ears, or mouth. in case of eye contact, flush eyes with water. ⢠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 seconds. ⢠rinse under running water and dry thoroughly. inactive ingredients citric acid, cocamide dea, d&c red 4, dmom hydantoin, ethyl alcohol, fd&c yellow 5, fragrance, isopropyl alcohol, sodium chloride, sodium laureth sulfate, water. choice liquid antibacterial soap with moisturizers contains .3% p.c.m.x. pn-5031-404uv-ch 800 ml choice box front label
Choice box back label choice liquid antibacterial soap liquid antibacterial soap ⢠antibacterial soap can help reduce bacteria on the hands that cause disease ⢠ph balanced ⢠produced in an fda registered facility ⢠cgmp facility ⢠mild formula for multiple handwashing without stripping the skin of its natural oils broad spectrum germ control made in the usa choice dispenser loading instructions 1. 2. 3. 4. section 1 section 2 section 3 section 4 choice box label back