Provon Antimicrobial Foam Handwash

Description

PROVON® Antimicrobial Foam Handwash is formulated with Chlorhexidine Gluconate 2% Solution, serving as an antiseptic agent. The product is available in two dosage forms: a 42 fl oz (1250 mL) container, identified by NDC 21749-850-90, and a 40.5 fl oz (1200 mL) container, identified by NDC 21749-850-89. Both formulations are distributed by GOJO Industries, Inc., located in Akron, OH 44309. The product is manufactured in the USA with U.S. and foreign components. The product codes include GOJOADXFLBLC and GOJOLTXFLBLC for the respective sizes. For further information, contact GOJO at 800-321-9647 or 330-255-6000, or visit www.GOJO.com. All rights are reserved as of ©2019 by GOJO Industries, Inc.

Uses and Indications

This drug is indicated for use as a healthcare personnel handwash, assisting in the reduction of bacteria that may potentially cause disease. Additionally, it is indicated for use as a surgical hand scrub, significantly reducing the number of microorganisms on the hands and forearms prior to surgical procedures or patient care.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Surgical hand scrubbing requires the following procedure: Healthcare professionals should begin by wetting their hands and forearms with water. They should then dispense 5 mL of the product and scrub for 3 minutes, utilizing 6 full strokes with a wet brush. Special attention must be given to the nails, cuticles, and the skin between the fingers. A separate nail cleaner may be employed if necessary. After scrubbing, hands should be rinsed thoroughly. Following this initial scrub, an additional wash is required, where the same amount of product (5 mL) is used for another 3 minutes of scrubbing, again with 6 full strokes. This should be followed by rinsing under running water and drying thoroughly.

For healthcare personnel handwashing, the process begins with wetting the hands with water. The individual should then dispense 5 mL of the product into cupped hands and wash vigorously for 15 seconds. This should be followed by rinsing under running water and drying thoroughly.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other component of the formulation. Additionally, it should not be used routinely in patients with wounds that extend beyond the superficial layers of the skin due to the potential for adverse effects.

Care should be taken to avoid contact with the eyes, ears, and mouth, as exposure may result in serious and permanent injury, including potential deafness if introduced into the middle ear through perforated eardrums. In the event of contact with these areas, the solution should be rinsed out promptly and thoroughly with water.

Discontinue use and consult a healthcare professional if signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should be aware of the potential for severe allergic reactions associated with its use. Symptoms indicative of such reactions may include wheezing or difficulty breathing, shock, facial swelling, hives, and rash.

In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance without delay. Additionally, if any signs of irritation, sensitization, or allergic reaction occur, the healthcare provider should be consulted, as these may indicate a serious underlying condition.

It is crucial to keep this product out of reach of children. In cases of accidental ingestion, immediate medical help should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Notably, there is a significant allergy alert, as the product may cause severe allergic reactions. Symptoms of such reactions can include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

It is important to note that individuals with a known allergy to chlorhexidine gluconate or any other ingredient in this product should not use it.

Additionally, patients should stop using the product and consult a healthcare professional if they experience irritation, sensitization, or any signs of an allergic reaction, as these may indicate a serious condition.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Provon Antimicrobial Foam Handwash (chlorhexidine gluconate 2%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly premature infants and those under 2 months of age, should use this product with caution due to the potential for irritation or chemical burns. It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Geriatric Use

Elderly patients should be monitored closely when using this medication, particularly those who are premature or under 2 months of age, as these populations may experience increased sensitivity. The potential for irritation or chemical burns necessitates caution in administration.

Healthcare providers are advised to assess the risks and benefits of treatment in geriatric patients, ensuring that appropriate safety measures are in place. Regular monitoring for adverse effects is recommended to mitigate any potential complications associated with the use of this medication in the elderly population.

Pregnancy

Pregnant patients should be advised to use this product with caution, particularly in the context of premature infants or infants under 2 months of age. There is a potential risk of irritation or chemical burns associated with the use of this product in these vulnerable populations. Healthcare professionals are encouraged to weigh the benefits against the risks when considering the use of this product in pregnant patients, especially those who may be at risk of delivering prematurely or who have recently given birth to infants in the specified age group.

Lactation

Lactating mothers should use this product with caution, particularly in the case of premature infants or those under 2 months of age. There is a risk that the product may cause irritation or chemical burns in breastfed infants. Therefore, careful consideration and monitoring are advised when administering this product to lactating mothers who are nursing young infants.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may also be beneficial in guiding the management of the overdose.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the potential for severe allergic reactions associated with this product. Reported symptoms of such reactions may include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, it is advised to discontinue use and seek immediate medical assistance.

Additionally, users are cautioned to stop use and consult a healthcare professional if signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition. Special care should be exercised when using this product in premature infants or infants under 2 months of age, as it may lead to irritation or chemical burns.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if they experience any irritation, sensitization, or allergic reactions, as these may indicate a serious condition.

When using this product, it is crucial to avoid contact with the eyes, ears, and mouth. Patients should be made aware that exposure to the eyes may result in serious and permanent injury, and instillation in the middle ear through perforated eardrums may lead to deafness. If the solution comes into contact with these areas, patients should rinse thoroughly and promptly with water.

Additionally, healthcare providers should caution patients against routine use of this product if they have wounds that extend beyond the superficial layers of the skin, as this may pose additional risks.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20-25° C (68-77° F). Care must be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40° C (104° F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

The product is administered topically. Clinicians should exercise caution when using this product in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. Patients should be advised to discontinue use and seek medical assistance immediately if an allergic reaction occurs. Additionally, it is important to keep the product out of reach of children; if ingested, medical help or contact with a Poison Control Center should be sought without delay.

Drug Information (PDF)

This file contains official product information for Provon Antimicrobial Foam Handwash, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)