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 catalog number GOJOADXFLBLC, and a 40.5 fl oz (1200 mL) container, identified by NDC 21749-850-89 and catalog number GOJOADXBLBLB. This handwash is manufactured by GOJO, ensuring a reliable antiseptic solution for hand hygiene.

Uses and Indications

This drug is indicated for use as a healthcare personnel handwash to help reduce bacteria that potentially can 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 surgery or patient care.

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

Dosage and Administration

Healthcare personnel should perform handwashing by first wetting their hands with water. They should then dispense 5 mL of the product, equivalent to 6 full strokes, into cupped hands. The hands should be washed vigorously for a duration of 15 seconds, followed by rinsing under running water and drying thoroughly.

For surgical hand scrubbing, healthcare personnel must wet their hands and forearms with water. They should scrub for 3 minutes using 5 mL of the product (6 full strokes) along with a wet brush, ensuring to pay close attention to the nails, cuticles, and the skin between the fingers. A separate nail cleaner may be utilized if necessary. After this initial scrub, it is essential to rinse thoroughly. Subsequently, personnel should wash for an additional 3 minutes with another 5 mL of the product (6 full strokes), 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, the product 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 in deeper tissue.

Warnings and Precautions

For external use only. This product carries a significant risk of severe allergic reactions. Healthcare professionals should be vigilant for symptoms such as wheezing, difficulty breathing, shock, facial swelling, hives, or rash. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

Patients should be advised not to use this product if they have a known allergy to chlorhexidine gluconate or any other component of the formulation.

In cases of ingestion, immediate medical attention is required. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay.

Healthcare providers should also counsel patients to discontinue use and consult a physician if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious underlying condition.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Notably, there is a significant risk of severe allergic reactions, which may manifest as wheezing or difficulty breathing, shock, facial swelling, hives, or rash. In the event of any allergic reaction, it is imperative that patients discontinue use immediately and seek medical assistance.

Additionally, patients who are known to be allergic to chlorhexidine gluconate or any other ingredient in this product should refrain from its use.

It is also advised that patients stop using the product and consult a healthcare professional if they experience irritation, sensitization, or any signs of an allergic reaction, as these symptoms may indicate a serious underlying 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 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 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 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 is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, alterations in consciousness, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may include the following steps:

1. Assessment: Conduct a thorough evaluation of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide symptomatic treatment as necessary, which may involve intravenous fluids, oxygen supplementation, or other interventions based on the patient's condition.

3. Decontamination: If the overdose is recent and the patient is alert, activated charcoal may be considered to limit further absorption of the substance.

4. Consultation: Engage with a poison control center or toxicology specialist for guidance on specific antidotes or advanced management strategies, if applicable.

Healthcare professionals should remain vigilant and prepared to implement these measures promptly to mitigate the potential effects of an overdose.

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 several adverse reactions reported voluntarily or through surveillance programs.

Allergic reactions, including anaphylaxis, have been documented. Skin reactions such as rash, pruritus, and dermatitis have also been reported. Additionally, there have been cases of eye injury, which may result in serious and permanent damage if the solution enters the eye. Chemical burns have been noted, particularly in premature infants or infants under 2 months of age.

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 these areas may result in serious and permanent eye injury or potential deafness if the solution is 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 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

No further data are available.

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)