Provon Antimicrobial Foam Handwash

Description

Chlorhexidine Gluconate 2% Solution is an antiseptic foam handwash formulated for effective hand hygiene. It is distributed by Gojo Industries, Inc., located in Akron, OH, USA. The product is available in a net weight of 18 fluid ounces (535 mL). The National Drug Code (NDC) for this formulation is 21749-850-53. For further information, the company can be contacted at 330-255-6000 or through their website at www.gojo.com.

Uses and Indications

This drug 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. Additionally, it is indicated for healthcare personnel handwashing, aiding in the reduction of bacteria that may potentially cause disease.

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

Dosage and Administration

Healthcare professionals are advised to follow the outlined procedures for the effective use of the solution in both surgical hand scrubs and healthcare personnel handwashing.

For the surgical hand scrub, the following steps should be adhered to:

1. Wet hands and forearms with water.

2. Dispense 5 ml of the solution and scrub for 3 minutes using a wet brush, ensuring thorough attention to the nails, cuticles, and interdigital spaces. A separate nail cleaner may be utilized if necessary.

3. Rinse hands and forearms thoroughly.

4. Repeat the process by washing for an additional 3 minutes with another 5 ml of the solution, followed by rinsing under running water.

5. Ensure hands and forearms are dried thoroughly after the final rinse.

For the healthcare personnel handwash, the procedure is as follows:

1. Wet hands with water.

2. Dispense 5 ml of the solution (equivalent to 4 full strokes) into cupped hands.

3. Wash hands vigorously for 15 seconds, ensuring all areas are covered, and then rinse under running water.

4. Dry hands thoroughly after rinsing.

Adhering to these protocols will help maintain optimal hygiene standards in clinical settings.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other component of the formulation.

Additionally, the product should not be used in patients with wounds that extend beyond the superficial layers of the skin, as this may pose a risk of adverse effects.

Warnings and Precautions

For external use only. This product should not be used by individuals who are allergic to chlorhexidine gluconate or any other ingredient contained in the formulation.

Healthcare professionals are advised to instruct patients to discontinue use and seek medical advice if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

General precautions must be observed to ensure safe use of this product. It is imperative to keep the solution away from the eyes, ears, and mouth, as contact with these areas may result in serious and permanent eye injury or potential deafness if instilled in the middle ear through perforated eardrums. Should the solution inadvertently come into contact with these sensitive areas, it is crucial to rinse thoroughly and promptly with water.

Additionally, this product should not be used routinely on wounds that extend beyond the superficial layers of the skin, as this may pose further risks to patient safety.

Side Effects

For external use only. Patients should not use this product if they are allergic to chlorhexidine gluconate or any other ingredient in this formulation.

In clinical practice, it is important to monitor for signs of irritation, sensitization, or allergic reactions. Should any of these adverse reactions occur, patients are advised to stop use immediately and consult a healthcare professional, as these symptoms may indicate a serious condition.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

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 be treated with caution. The use of these products in this population may lead to irritation or chemical burns. It is essential for healthcare professionals to closely monitor these patients to mitigate potential risks associated with their use.

Geriatric Use

Elderly patients should be monitored closely when using this medication, particularly those who are premature infants or infants under 2 months of age. The use of this product in these populations may lead to irritation or chemical burns. Caution is advised, and healthcare providers should consider the potential risks associated with its use in these vulnerable groups. Regular assessment of the patient's condition and response to treatment is recommended to ensure safety and efficacy.

Pregnancy

There are no specific statements regarding the use of PROVON ANTIMICROBIAL FOAM HANDWASH (chlorhexidine gluconate 2% solution) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should consider the absence of data when advising women of childbearing potential regarding the use of this product during pregnancy. It is recommended that the potential benefits and risks be evaluated on a case-by-case basis.

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

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, including anaphylaxis, as well as skin reactions such as rash, pruritus, and urticaria.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. 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 essential to keep it away from the eyes, ears, and mouth. Patients should be made aware that the product may cause serious and permanent eye injury if it enters the eye or may lead to deafness if instilled in the middle ear through perforated eardrums. In the event of contact with these areas, patients should rinse thoroughly and promptly with water.

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

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20-25° C (68-77° F). Care should 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 advise patients to use the product with caution in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. It is crucial to avoid contact with the eyes, ears, and mouth, as exposure can lead to serious and permanent eye injury or deafness if instilled in the middle ear through perforated eardrums. In the event of contact with these areas, patients should rinse thoroughly with water.

Patients are also cautioned against routine use on wounds that extend beyond the superficial layers of the skin. They should discontinue use and consult a healthcare professional if any irritation, sensitization, or allergic reaction occurs, as these may indicate a serious condition. Additionally, the product should be kept out of reach of children, and immediate medical assistance should be sought if ingested.

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)