Purell Antimicrobial Foam

Description

NDC 21749-225-53. Purell FOAM HANDWASH contains Chlorhexidine Gluconate 2% Solution, an antiseptic with broad-spectrum efficacy. This formulation is designed to be gentle on hands while providing effective antimicrobial action. The product is classified as a 2% CHG ANTIMICROBIAL FOAM. It is distributed by GOJO Industries, Inc., located in Akron, OH 44309. For inquiries, contact 800-321-9647 or 330-255-6000, or visit www.GOJO.com. The product is made in the U.S.A. and is subject to copyright ©2019 by GOJO Industries, Inc. All rights reserved. Reorder number is 5742-06, with the internal code GOJOBLUE18LBLB and additional identifier 5742-643.

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 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 six full strokes, into cupped hands. The 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 both hands and forearms with water. They are to scrub for 3 minutes using 5 mL of the product (six full strokes), employing a wet brush to ensure attention is given 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 (six full strokes), after which personnel must 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

For external use only. This product carries a significant risk of 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 potentially permanent eye injury or 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.

Healthcare professionals 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.

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

Side Effects

Patients should be aware that this product is for external use only. There is a significant allergy alert associated with its use, as it may cause a severe allergic reaction. Symptoms of such a reaction may 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.

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 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 two 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

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be advised to use this product with caution, particularly in the context of premature infants or infants under two 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 if there is a possibility of exposure to infants.

Lactation

Lactating mothers should use this product with caution, particularly in the case of premature infants or those under two 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.

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

Overdosage may result in serious adverse effects. In the event of an overdose, it is imperative to seek medical attention immediately. Prompt intervention is crucial to mitigate potential complications associated with overdosage. Healthcare professionals should be vigilant in monitoring patients for any signs of adverse reactions and provide appropriate management as necessary.

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 several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions, which may manifest as severe symptoms such as wheezing, difficulty breathing, shock, facial swelling, hives, and rash. Additionally, instances of irritation, sensitization, or allergic reactions have been noted, which could 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 to disclose any known allergies to chlorhexidine gluconate or any other ingredients in the product prior to use. It is essential to emphasize that while using this product, it should be kept away from the eyes, ears, and mouth, as contact with these areas may lead to serious and permanent eye injury or potential deafness if instilled in the middle ear through perforated eardrums.

In the event that the solution comes into contact with the eyes, ears, or mouth, patients should rinse the affected area promptly and thoroughly 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.

Patients should be advised to stop using the product and consult a healthcare professional if they experience any irritation, sensitization, or allergic reactions, as these may indicate a serious condition requiring medical attention.

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 20-25ºC (68-77ºF). Care must be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40ºC (104ºF). 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 two months of age, as it may cause irritation or chemical burns. It is also important to keep the product out of reach of children; if ingested, 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.

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