Foaming Hand Wash

Description

No description information is available for the specified drug.

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 specified procedures for the surgical hand scrub and healthcare personnel handwash to ensure optimal hygiene and effectiveness.

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

1. Begin by wetting hands and forearms with water.

2. Dispense 5 mL of the product and scrub for 3 minutes using a wet brush, ensuring to perform 7 strokes while paying particular attention to the nails, cuticles, and the skin between the fingers. 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 product, again using 7 strokes. Rinse under running water and dry thoroughly.

For the healthcare personnel handwash, the following procedure is recommended:

1. Wet hands with water.

2. Dispense 5 mL of the product into cupped hands and wash vigorously for 15 seconds.

3. Rinse hands thoroughly and dry completely.

Adhering to these guidelines will help maintain proper hand hygiene 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 routinely in patients with wounds that extend beyond the superficial layers of the skin due to the potential for adverse effects.

Contact with the eyes, ears, or mouth is contraindicated, as exposure may result in serious and permanent eye injury or deafness if introduced into the middle ear through perforated eardrums. In the event of contact with these areas, it is imperative to rinse thoroughly with water.

Warnings and Precautions

For external use only. This product carries a significant risk of causing severe allergic reactions. 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.

General precautions must be observed to ensure safe application. The product should be kept away from the eyes, ears, and mouth, as contact with these areas may result in serious and permanent eye injury or potential deafness if introduced into the middle ear through perforated eardrums. Should the solution inadvertently contact these sensitive areas, it is essential to rinse thoroughly and promptly with water. Additionally, the product should not be used routinely on wounds that extend beyond the superficial layers of the skin.

In cases of ingestion, immediate medical help should be sought, or a Poison Control Center should be contacted without delay.

Healthcare professionals should advise 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 potential for severe allergic reactions, which may manifest as wheezing or difficulty breathing, shock, facial swelling, hives, or rash. Individuals with a known allergy to chlorhexidine gluconate or any other ingredient in this product should not use it.

During the use of this product, it is critical to avoid contact with the eyes, ears, and mouth, as exposure may lead to serious and permanent eye injury or 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 with water immediately.

Patients are advised to discontinue use and consult a healthcare professional if they experience irritation, sensitization, or any signs of an allergic reaction, as these may indicate a serious condition. Additionally, the product should not be used routinely on wounds that extend beyond the superficial layers of the skin.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Foaming Hand Wash (chlorhexidine gluconate). 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 careful consideration and caution in this demographic.

While specific dosage adjustments for geriatric patients are not provided, healthcare providers are advised to assess the overall health status and individual response to treatment in elderly patients. Regular monitoring for adverse effects is recommended to ensure safety and efficacy in this age group.

Pregnancy

There is no specific information available regarding the use of Foaming Hand Wash containing chlorhexidine gluconate during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks associated with the use of this product during pregnancy.

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 drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as there is no available data to guide dosing or monitoring in this population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient's vital signs and clinical status is recommended to ensure appropriate interventions are implemented in a timely manner.

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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: irritation, sensitization, and allergic reactions. These reactions may indicate the presence of a serious condition.

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 not to use the product if they have a known allergy to chlorhexidine gluconate or any other ingredient contained in the formulation. It is important to counsel patients 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, healthcare providers should emphasize the importance of avoiding 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 with water.

Additionally, healthcare providers should advise patients against routine use of the 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), to maintain product integrity. Proper container requirements should be adhered to, ensuring that the product is kept in suitable conditions to prevent degradation. Special handling needs should be observed to ensure the product remains within the recommended temperature range throughout its storage and handling processes.

Additional Clinical Information

Surgical hand scrubbing requires a total of 6 minutes of product application, divided into two phases. Initially, clinicians should scrub for 3 minutes using 5 mL of the product (7 strokes) with a wet brush, followed by thorough rinsing. This is succeeded by an additional 3-minute wash with another 5 mL of the product (7 strokes), rinsing under running water and ensuring thorough drying.

For healthcare personnel handwashing, 5 mL of the product (7 strokes) should be dispensed into cupped hands, followed by vigorous washing for 15 seconds, followed by rinsing and thorough drying. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Foaming Hand Wash, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)