Antiseptic Foam Handwash
Chlorhexidine Gluconate 2% Solution
Gojo Industries, Inc.
Human Otc Drug
NDC 21749-461Antiseptic Foam Handwash also known as Chlorhexidine Gluconate 2% Solution is a human otc drug labeled by 'Gojo Industries, Inc.'. National Drug Code (NDC) number for Antiseptic Foam Handwash is 21749-461. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Antiseptic Foam Handwash drug includes Chlorhexidine Gluconate - 20 mg/mL . The currest status of Antiseptic Foam Handwash drug is Active.
Drug Information:
| Drug NDC: | 21749-461 |
| 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: | Antiseptic Foam Handwash |
| 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: | Chlorhexidine Gluconate 2% Solution |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Gojo Industries, 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: | CHLORHEXIDINE GLUCONATE - 20 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: | NDA |
| 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 Dec, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| 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: | NDA019422 |
| 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: | GOJO Industries, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1245230
|
| 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: | MOR84MUD8E
|
| 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. |
| Pharmacologic Class: | Decreased Cell Wall Integrity [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 21749-461-89 | 1200 mL in 1 BOTTLE (21749-461-89) | 01 Dec, 2011 | 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 a general purpose antimicrobial handwash, which kills germs that may cause disease. un nettoyant pour les mains antimicrobien á large spectre qui élimine les micro-organismes susceptibles de provoquer des maladies.
Product Elements:
Antiseptic foam handwash chlorhexidine gluconate 2% solution hydroxyethyl cellulose (2000 cps at 1%) chlorhexidine gluconate chlorhexidine water isopropyl alcohol coco diethanolamide citric acid monohydrate lauramine oxide
Indications and Usage:
Indications antiseptic cleanser kills harmful bacteria or germs. dosage: this product should be used daily, as part of the daily cleansing routine nettoyant antiseptique tue les bactéries ou les germes nocifs. posologie: utiliser par jour, dan le cadre du régime de nettoyage quotidien.
Warnings:
Warnings/mises en garde this product is intended for external use only. contact with the eyes should be avoided and should this occur, the eye should be flushed with water. if irritation develops or increases, use of the product should be disontinued. if irritattion persists for moe than 5 days, consult a physician. keep out of reach of children. pour usage externe seulement, éviter tout contact avec les yeux, le cas échéant, rincer abondamment avec de l'eau, si une irritation apparaÃt ou s'accentue, cesser l'empoli. si l'irritation persiste pendant plus de 5 jours, consulter un médcin. garder hors de portée des enfants.
Dosage and Administration:
Directions/mode d'emploi wet hands. apply an adequate amount of soap and work into a rich lather for 15-30 seconds. rinse thoroughly with water. dry hands completely. se mouiller les maines. appliquer une quantité adéquate de savon et frotter les mains pendant 15 á 30 secondes jusqu á obtenir une mousse abondante. rincer abondamment á l'eau. sécher soigneusement.
Package Label Principal Display Panel:
Ndc 21749-461-89 chlorhexidine gluconate 2% solution antiseptic lotion soap distributed by: gojo industries, inc. akron, oh 44309 330-255-6000 www.gojo.com gojo canada, inc. 1100 squires beach road pickering, on l1w 3n8 frontttfxcanlblb ndc 21749-461-89 chlorhexidine gluconate 2% solution antiseptic lotion soap distributed by: gojo industries, inc. akron, oh 44309 330-255-6000 www.gojo.com gojo canada, inc. 1100 squires beach road pickering, on l1w 3n8 backgojocanlbla pdp page 1 page 2