Purklenz
Chloroxylenol
Purklenz Formulations Inc.
Human Otc Drug
NDC 49436-291Purklenz also known as Chloroxylenol is a human otc drug labeled by 'Purklenz Formulations Inc.'. National Drug Code (NDC) number for Purklenz is 49436-291. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Purklenz drug includes Chloroxylenol - 2.949 g/100mL . The currest status of Purklenz drug is Active.
Drug Information:
| Drug NDC: | 49436-291 |
| 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: | Purklenz |
| 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: | Chloroxylenol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Purklenz Formulations Inc. |
| 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 - 2.949 g/100mL
|
| 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 May, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 12 Jun, 2026 |
| 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: | part333E |
| 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: | 31 Dec, 2023 |
| 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: | PurKlenz Formulations Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 247396
1537468
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 0F32U78V2Q
|
| 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 |
|---|
| 49436-291-01 | 900 mL in 1 BOTTLE, PLASTIC (49436-291-01) | 01 May, 2012 | N/A | No |
| 49436-291-02 | 3780 mL in 1 BOTTLE (49436-291-02) | 01 May, 2012 | N/A | No |
| 49436-291-03 | 1000 PACKET in 1 BOX (49436-291-03) / 3.5 mL in 1 PACKET | 01 May, 2012 | N/A | No |
| 49436-291-05 | 500 mL in 1 BOTTLE, PLASTIC (49436-291-05) | 01 May, 2012 | N/A | 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 purpose: antiseptic
Product Elements:
Purklenz chloroxylenol chloroxylenol chloroxylenol water sodium laureth sulfate propylene glycol cocamidopropyl betaine ppg-2 hydroxyethyl cocamide hypromelloses citric acid monohydrate edetate sodium lanolin oil
Indications and Usage:
Uses to decrease bacteria on the skin
Warnings:
Warnings for external use only do not use if you are allergic or sensitive to any of the ingredients listed when using this product avoid contact in or near eyes and mouth (oral mucosa). in case of eye contact, flush eyes with water. stop and ask a doctor if irritation, rash or other allergic reaction develops. in case of accidental ingestion seek medical help or contact a poison control center right away.
Dosage and Administration:
Directions for best results do not dilute apply as needed scrub thoroughly for 30 seconds wipe excess with sterile gauze repeat - liquid only massage package and remove towelette - towelette only fold gauze and repeat - towelette only
Package Label Principal Display Panel:
Purklenz antiseptic skin cleaner label - 30 fl oz purklenz® antiseptic skin cleanser chloroxylenol 3.0 % no paraben ⢠alcohol ⢠dye ⢠fragrance⢠contains no paraben, fragrance or dye 30 fl. oz. (900 ml) ndc 49436-291-01 made in canada distributed in u.s.a. by purklenz formulations inc. questions or comments? www.purklenz.com purklenz purklenz formulations inc. purklenz antisepticskin 5 label
Purklenz antiseptic skin cleanser - towelette label purklenz® antiseptic skin cleanser contains no paraben, fragrance and dye 1 pre-moistened single use towelette 4" x 6" net content 3.5 ml ndc 494-291-03 purklenz antitowellette label purklenz antitowelette 1 label
Purklenz antiseptic skin cleaner - drum label purklenz® antiseptic skin cleanser gross weight 111 kg (278 lbs) net weight 105 kg (263 lbs) volume 105 liters (28 gallons) ndc 494-291-99lot 4d1 made in canada expiry april 2016 purklenze formulations inc. purklenz drum label
Purklenz antiseptic skin cleaner label - 16 fl oz purklenz ® antiseptic skin cleanser no - paraben â alcohol â dye - fragrance 500ml (16 fl. oz.) ndc: 49436-291-05 product facts active ingredien purpose: chloroxylenol 3%.............................antiseptic uses: to decrease bacteria on the skin. warnings: for external use only. do not ingest. do not use if you are allergic or sensitive to any of the ingredients listed. when using this produc t avoid contact in or near eyes and mouth (oral mucosa). in case of eye contact, flush eyes with water. stop use & ask a doctor if irritation, rash or other allergic reaction develops. keep out of reach of children. in case of accidental ingestion, seek medical help or contact a poison control center right away. directions: for best results do not dilute apply as needed scrub thoroughly for at least 30 seconds rinse repeat other information: avoid freezing. store between 4Ëc and 30Ëc (40Ëf and 86Ëf) inactive ingredients: water (aqua), sodium laureth sulfate, propylene glycol, cocamidopropyl betaine, ppg-2 hydroxyethyl cocamide, hypromellose, citric acid, tetrasodium edta, lanolin oil made in canada distributed in u.s.a. by purklenz formulations inc. questions or comments? www.purklenz.com purklenz 500ml 05