Provon Antimicrobial Foam Handwash
Chlorhexidine Gluconate 2%
Gojo Industries, Inc.
Human Otc Drug
NDC 21749-850Provon Antimicrobial Foam Handwash also known as Chlorhexidine Gluconate 2% is a human otc drug labeled by 'Gojo Industries, Inc.'. National Drug Code (NDC) number for Provon Antimicrobial Foam Handwash is 21749-850. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Provon Antimicrobial Foam Handwash drug includes Chlorhexidine Gluconate - 20 mg/mL . The currest status of Provon Antimicrobial Foam Handwash drug is Active.
Drug Information:
| Drug NDC: | 21749-850 |
| 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: | Provon Antimicrobial 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% |
| 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: | Solution |
| 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 Jul, 2016 |
| 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 |
|---|
| 21749-850-89 | 1200 mL in 1 BOTTLE, DISPENSING (21749-850-89) | 01 Jul, 2016 | N/A | No |
| 21749-850-90 | 1250 mL in 1 BOTTLE, DISPENSING (21749-850-90) | 01 Jul, 2016 | 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 antiseptic
Product Elements:
Provon antimicrobial foam handwash chlorhexidine gluconate 2% citric acid monohydrate coco diethanolamide hydroxyethyl cellulose (2000 mpa.s at 1%) isopropyl alcohol lauramine oxide water chlorhexidine gluconate chlorhexidine
Indications and Usage:
Uses healthcare personnel handwash: helps reduce bacteria that potentially can cause disease surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
Warnings:
Warnings for external use only allergy alert: this product may cause a severe allergic reaction. symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash if an allergic reaction occurs, stop use and seek medical help right away do not use if you are allergic to chlorhexidine gluconate or any other ingredient in this product
Do Not Use:
Warnings for external use only allergy alert: this product may cause a severe allergic reaction. symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash if an allergic reaction occurs, stop use and seek medical help right away do not use if you are allergic to chlorhexidine gluconate or any other ingredient in this product
When Using:
When using this product keep out of eyes, ears, and mouth. may cause serious and permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardrums if solution should contact these areas, rinse out promptly and thoroughly with water do not use routineely if you have wounds which involve more than the superficial layers of the skin stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. these may be signs of a serious condition. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions use with care in premature infants or infants under 2 months of age. these products may cause irritation or chemical burns. surgical hand scrub: wet hands and forearms with water scrub for 3 minutes with 5 ml of product (6 full strokes), with a wet brush, paying close attention to the nails, cuticles, and skin between the fingers a separate nail cleaner may be used rinse thoroughly wash for an additional 3 minutes with 5 ml of product (6 full strokes) and rinse under running water and dry thoroughly healthcare personnel handwash: wet hands with water dispense 5 ml of product (6 full strokes) into cupped hands and wash in a vigorous manner for 15 seconds and rinse under running water and dry thoroughly
Stop Use:
Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. these may be signs of a serious condition.
Package Label Principal Display Panel:
Provon® antimicrobial foam handwash chlorhexidine gluconate 2% solution - antiseptic gojoadxflblc 8842-643-f provon® antimicrobial foam handwash chlorhexidine gluconate 2% solution - antiseptic gojoltxflblc 1922-643-f adx front ltx front package label. secondary display panel ndc 21749-850-90 brought to you by gojo provon® brand antimicrobial foam handwash with 2% chg chlorhexidine gluconate 2% solution - antiseptic distributed by: gojo industries, inc. akron, oh 44309 800-321-9647 ⢠330-255-6000 www.gojo.com ©2019. gojo industries, inc. all rights reserved. made in u.s.a. gojoadxblblb 8842-642-b 42 fl oz (1250 ml) ndc 21749-850-89 brought to you by gojo provon® brand antimicrobial foam handwash with 2% chg chlorhexidine gluconate 2% solution - antiseptic distributed by: gojo industries, inc. akron, oh 44309 800-321-9647 ⢠330-255-6000 www.gojo.com ©2019. gojo industries, inc. all rights reserved. made in the usa with u.s. and foreign components gojoltxblblb 1922-642-b 40.5 fl oz (1200 ml) adx back pdp adx back drug facts 1 adx back drug facts 2 ltx back pdp ltx back drug facts 1 ltx back drug facts 2