Bd E-Z Scrub

Description

BD E-Z Scrub™ is a 4% chlorhexidine gluconate solution, formulated as an antiseptic. It is supplied in a 32 fl oz (946 mL) container, with the National Drug Code (NDC) 17271-505-01 and reference number REF 372402. The product is protected by U.S. Patents 6,053,369 and 6,308,866, along with foreign patents and patents pending.

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

Surgical hand scrubbing requires the following steps for effective preparation. First, healthcare professionals should wet their hands and forearms with water. They should then apply approximately 2.0 cubic inches of the product and scrub for a duration of 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. Following the initial scrub, hands must be rinsed thoroughly.

An additional washing phase is required, where the same amount of product (2.0 cubic inches) should be applied for another 3 minutes of scrubbing, followed by rinsing under running water. It is essential to dry hands thoroughly after completing the surgical hand scrub.

For healthcare personnel handwashing, the process begins with wetting the hands with water. Approximately 1.5 cubic inches of the product should be dispensed into cupped hands. The hands should be washed vigorously for 15 seconds, followed by rinsing under running water. Thorough drying of the hands is also necessary after this procedure.

Contraindications

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

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.

Individuals with a known allergy to chlorhexidine gluconate or any other component of this product should refrain from its use.

When administering this product, it is crucial 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. Should the solution come into contact with these areas, it must be rinsed out promptly and thoroughly with water. Additionally, this product should not be used routinely on wounds that extend beyond the superficial layers of the skin.

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 condition.

To ensure safety, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical attention should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware that it is for external use only. There is a potential for severe allergic reactions, which may manifest as symptoms including 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.

This product should not be used by individuals who are allergic to chlorhexidine gluconate or any other ingredient contained in the formulation. During use, it is crucial to avoid contact with the eyes, ears, and mouth, as exposure to these areas may result in serious and permanent eye injury or deafness if the solution enters the middle ear through perforated eardrums. Should the solution come into contact with these sensitive areas, it is recommended to rinse thoroughly with water.

Patients are also cautioned against routine use of this product on wounds that extend beyond the superficial layers of the skin. If irritation, sensitization, or any signs of an allergic reaction occur, it is important to stop use and consult a healthcare professional, as these may indicate a serious condition.

Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical help should be sought or contact with a Poison Control Center is recommended.

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 Bd E-Z Scrub (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 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 dosages as necessary 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 exposure to premature or very young infants.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals should advise caregivers to contact a Poison Control Center without delay.

Prompt action is crucial in managing potential overdosage situations to mitigate risks and ensure patient safety.

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: allergic reactions, which may include severe manifestations such as wheezing, difficulty breathing, shock, facial swelling, hives, and rash.

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 contact with these areas may result in serious and permanent eye injury or deafness if the solution is instilled in the middle ear through perforated eardrums. If the solution does come into 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 lead to complications.

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 storage conditions are essential to ensure the efficacy and safety of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Bd E-Z Scrub, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)