Bd E-Z Scrub

Description

BD E-Z Scrub is a Chlorhexidine Gluconate 4% solution antiseptic, available in a dosage form of 32 fluid ounces (946 mL). The product is identified by NDC 17271-505-02 and is also available under NDC 17271-505-01. It is associated with REF numbers 372412 and 372402. The formulation is protected by U.S. Patent 6,427,875, along with additional U.S. Patents 6,053,369 and 6,308,866, and is subject to 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 scrubs should begin with the healthcare professional wetting their hands and forearms with water. Approximately 2.0 cubic inches of the product should be applied using a wet brush, ensuring a thorough scrub for a duration of 3 minutes. Special attention must be given to the nails, cuticles, and interdigital spaces; a separate nail cleaner may be utilized if necessary. Following the initial scrub, hands should be rinsed thoroughly.

An additional scrub is required, where the professional should again apply 2.0 cubic inches of the product and wash for another 3 minutes, followed by rinsing under running water. It is essential to dry hands thoroughly after the final rinse.

For healthcare personnel handwashing, the process begins with wetting the hands with water. The individual should dispense 1.5 cubic inches of the product into cupped hands and wash vigorously for 15 seconds. After washing, hands must be rinsed under running water and dried 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 the event of irritation, sensitization, or an allergic reaction, discontinue use and consult a healthcare professional, as these symptoms may indicate a serious condition.

Care should be taken to avoid contact with the eyes, ears, and mouth, as exposure may result in serious and permanent eye injury or hearing loss if introduced into the middle ear through perforated eardrums. If contact occurs, the affected area should be rinsed thoroughly with water.

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 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.

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.

It is essential to keep this product out of reach of children. In cases of accidental ingestion, immediate medical attention should be sought, or contact with a Poison Control Center is recommended.

Care should be taken to avoid contact with the eyes, ears, and mouth, as exposure may lead to serious and permanent eye injury or potential deafness if the solution is instilled into the middle ear through perforated eardrums. Should the solution come into contact with these areas, it is crucial to rinse thoroughly and promptly with water.

Routine use of this product is not recommended for individuals with wounds that extend beyond the superficial layers of the skin, as this may exacerbate the condition.

Side Effects

Patients using this product may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Severe allergic reactions have been reported, 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.

It is important to note that this product should not be used by individuals who are allergic to chlorhexidine gluconate or any other ingredient contained in the formulation.

During the use of this product, patients should take precautions to avoid contact with the eyes, ears, and mouth, as exposure to these areas may lead to serious and permanent eye injury or potential deafness if the solution is instilled in the middle ear through perforated eardrums. Should the solution come into contact with these sensitive areas, it is crucial to rinse thoroughly with water.

Patients are also 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 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 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 be treated with caution. The use of these products in this population may lead to irritation or chemical burns. It is essential for healthcare professionals to monitor these patients closely to mitigate potential risks associated with their use.

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 caution in administration. It is advisable to consider the specific needs and health status of geriatric patients when determining the appropriateness of this treatment, ensuring that any risks are carefully weighed against the benefits.

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 drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

Postmarketing experience has revealed that the use of chlorhexidine gluconate may be associated with severe allergic reactions. Reported symptoms include wheezing, difficulty breathing, shock, facial swelling, hives, and rash. Additionally, there have been reports of irritation, sensitization, or allergic reactions, which may indicate a serious condition. Caution is advised when using this product 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 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. Currently, there are no specified storage or handling conditions outlined in the provided information. Therefore, it is recommended that healthcare professionals refer to the product's official labeling or consult with the manufacturer for any additional details regarding storage and handling requirements.

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)