Purell Antimicrobial Foam

Description

Purell Healthcare FOAM HANDWASH 2% CHG is an antimicrobial foam formulation designed for effective hand hygiene. The product is available in two sizes: 42 fl oz (1250 mL) and 40.5 fl oz (1200 mL). It is distributed by GOJO Industries, Inc., located in Akron, OH 44309. The product is manufactured in the USA using both U.S. and foreign components. For further information, contact GOJO Industries at 800-321-9647 or 330-255-6000, or visit their website at www.GOJO.com. All rights to the product are reserved as of 2019.

Uses and Indications

This drug is indicated for use as a healthcare personnel handwash, assisting in the reduction of bacteria that can potentially cause disease. It is also 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

Healthcare personnel should adhere to the following procedures for hand hygiene using the specified product.

For routine handwashing, healthcare personnel must first wet their hands with water. They should then dispense 5 mL of the product, which is equivalent to 6 full strokes, into cupped hands. Hands should be washed vigorously for a duration of 15 seconds, ensuring thorough coverage. After washing, hands must be rinsed thoroughly and dried completely.

In the case of a surgical hand scrub, healthcare personnel should begin by wetting their hands and forearms with water. They are to scrub for 3 minutes using 5 mL of the product (6 full strokes), employing a wet brush and paying particular attention to the nails, cuticles, and the skin between the fingers. A separate nail cleaner may be utilized if necessary. Following this initial scrub, hands and forearms should be rinsed thoroughly. An additional scrub is required for 3 minutes using another 5 mL of the product (6 full strokes), after which personnel should rinse under running water and dry thoroughly.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other ingredient contained in 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.

Care should be taken to avoid contact with the eyes, ears, and mouth, as exposure may result in serious and permanent eye injury or deafness if instilled in the middle ear through perforated eardrums. In the event of contact with these areas, it is imperative to rinse thoroughly with water.

Discontinue use and consult a healthcare professional if irritation, sensitization, or an allergic reaction occurs, 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 an allergic reaction 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.

In cases where the product is ingested, emergency medical help should be sought without delay. Contacting a Poison Control Center is also recommended to ensure appropriate management.

Healthcare providers should advise patients to stop using the product and consult a physician if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious underlying condition. Monitoring for these adverse effects is essential to ensure patient safety and effective management of any complications that may arise.

Side Effects

Patients may experience severe allergic reactions to this product, which can manifest as wheezing or difficulty breathing, shock, facial swelling, hives, or rash. In the event of an allergic reaction, it is imperative that patients discontinue use immediately and seek medical assistance.

Additionally, patients are advised to 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 condition.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

Packaging & NDC

Below are the non-prescription pack sizes of Purell Antimicrobial Foam (chlorhexidine gluconate 2% solution). 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. It is essential to assess the individual patient's condition and adjust the treatment approach accordingly to ensure safety and efficacy.

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

Patients with renal impairment have not been specifically addressed in the available data 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 the lack of information necessitates careful clinical judgment and monitoring of these patients.

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 excessive dosing. Symptoms of overdosage 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Documentation of the incident, including the amount ingested and the time of ingestion, is crucial for effective management and follow-up care.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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. The product should be used with caution 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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is essential to inform patients not to use the product if they have a known allergy to chlorhexidine gluconate or any other ingredient contained in the formulation.

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

When discussing the application of this product, healthcare providers must 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 sensitive 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, 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 is essential to store the product at a controlled temperature range of 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), to maintain product integrity. Proper storage conditions are crucial for ensuring the efficacy and safety 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 essential to keep the product away from the eyes, ears, and mouth, as contact 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 signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition. In case of ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

Drug Information (PDF)

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

View product document (PDF)