Bd E-Z Scrub 107

Description

BD E-Z Scrub™ 107 is a surgical scrub brush/sponge and nail cleaner formulated with 4% chlorhexidine gluconate (CHG). Each unit contains 30 individual scrub brushes/sponge applicators. The product is identified by reference number 371073 and National Drug Code (NDC) 17271-107-03. It is protected under U.S. Patent 5,164,107.

Uses and Indications

This drug is indicated for the preoperative cleaning of healthcare personnel's arms and hands.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals are advised to follow the outlined procedure for effective hand and forearm scrubbing prior to surgical or clinical procedures.

Begin by wetting the hands and forearms up to the elbows with warm water. Utilize a nail cleaner to prepare the nails, then apply the scrub solution from the sponge side of the applicator. Work the solution into a lather.

Scrub the nails, cuticles, and interdigital spaces thoroughly for a duration of 3 minutes using the brush side of the applicator. During this time, also scrub the hands and forearms with the sponge side. After the initial scrubbing, rinse the hands and forearms with warm water.

Following the rinse, repeat the scrubbing process for an additional 3 minutes, using the sponge side only. It is important to add water as necessary to maintain the desired level of suds throughout this second scrubbing phase. Conclude the procedure by rinsing the hands and arms thoroughly with warm water.

Finally, ensure that the hands and forearms are dried thoroughly to complete the preparation for the subsequent procedure.

Contraindications

Use is contraindicated in individuals with a known sensitivity to chlorhexidine gluconate or its components.

Additionally, the product should not be used as a preoperative skin preparation for the face or head. It is also contraindicated for use in the eyes, ears, and mouth.

Warnings and Precautions

For external use only, this product is contraindicated in several specific situations. It should not be utilized as a preoperative skin preparation on the face or head, nor should it come into contact with the eyes, ears, or mouth. Additionally, individuals with a known sensitivity to chlorhexidine gluconate or its components should refrain from using this product.

When administering this product, it is crucial to avoid contact with the meninges. Chlorhexidine gluconate has been associated with the risk of causing deafness if instilled in the middle ear, particularly in cases of perforated eardrums. Furthermore, exposure of chlorhexidine gluconate solution to the eyes during surgical procedures can lead to serious and permanent eye injuries. Should the solution inadvertently contact these sensitive areas, it is imperative to rinse thoroughly and promptly with water.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any adverse reactions occur. Reports of irritation, sensitization, and generalized allergic reactions have been documented with chlorhexidine-containing products, particularly in the genital regions.

This product must be kept out of reach of children. In the event of accidental ingestion, or if the product comes into contact with the eyes or ears, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients should be aware that the product is for external use only. It is contraindicated for use as a preoperative skin preparation of the face or head, and it should not be applied in or around the eyes, ears, or mouth. Additionally, individuals with a known sensitivity to chlorhexidine gluconate or its components should avoid using this product.

During the use of this product, it is crucial to avoid contact with the meninges. Chlorhexidine gluconate has been associated with serious adverse reactions, including reports of deafness when instilled in the middle ear through perforated eardrums. Furthermore, there have been instances where chlorhexidine gluconate solution caused serious and permanent eye injuries when it entered and remained in the eye during surgical procedures. In the event that the solution contacts these sensitive areas, it is imperative to rinse thoroughly and promptly with water.

Patients are advised to discontinue use and consult a healthcare professional if any adverse reactions occur. Reports have indicated that irritation, sensitization, and generalized allergic reactions may arise with chlorhexidine-containing products, particularly in the genital areas.

Drug Interactions

Chlorhexidine gluconate is associated with significant risks when used in specific anatomical contexts.

When instilled in the middle ear through perforated eardrums, chlorhexidine gluconate has been reported to cause deafness. This interaction underscores the importance of avoiding the use of chlorhexidine in patients with known perforations of the tympanic membrane.

Additionally, chlorhexidine gluconate solution poses a risk of serious and permanent eye injury if it enters and remains in the eye during surgical procedures. It is crucial to implement measures to prevent exposure to the eyes during the use of this agent in surgical settings.

Healthcare professionals should exercise caution and ensure appropriate application techniques to mitigate these risks. Monitoring for any signs of auditory or ocular complications is advised in patients receiving chlorhexidine gluconate in contexts where these interactions may occur.

Packaging & NDC

Below are the non-prescription pack sizes of Bd E-Z Scrub 107 (chlorhexidine gluconate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, exposure to the eyes, or contact with the ears, immediate medical assistance should be sought, or a Poison Control Center should be contacted.

Geriatric Use

There is no specific information regarding the use of BD E-Z SCRUB 107 (chlorhexidine gluconate solution) in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when administering this product to elderly patients, as the absence of data necessitates careful monitoring and consideration of individual patient factors. It is advisable to assess the overall health status and any comorbidities of geriatric patients prior to use, given the lack of established guidelines for this population.

Pregnancy

Pregnant patients should be aware that there are no specific safety concerns or dosage modifications indicated for the use of this medication during pregnancy. Additionally, there are no special precautions outlined for pregnant individuals. As with any medication, healthcare professionals are encouraged to weigh the potential benefits against any risks when considering treatment options for pregnant patients. Further studies may be necessary to fully understand the implications of this medication on fetal outcomes. Women of childbearing potential should be informed of the importance of discussing their pregnancy status and any potential risks with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there are no specific considerations or precautions mentioned regarding lactation or the potential for excretion in breast milk.

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 drug. 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, immediate medical assistance is crucial. If the product is ingested, or if it comes into contact with the eyes or ears, healthcare professionals should be contacted without delay. It is recommended to reach out to a Poison Control Center for specialized guidance and support.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the situation and implement appropriate management strategies based on the specific circumstances of the exposure.

Nonclinical Toxicology

Irritation, sensitization, and generalized allergic reactions have been reported with chlorhexidine-containing products, particularly in the genital areas. No information is available regarding teratogenic effects, nonclinical toxicology, or animal pharmacology and toxicology.

Postmarketing Experience

Adverse reactions associated with chlorhexidine-containing products have been reported in postmarketing experience, particularly in the genital areas. These reactions include irritation, sensitization, and generalized allergic reactions. Reports of these events have been received voluntarily and through surveillance programs, contributing to the understanding of the safety profile of chlorhexidine-containing products.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or exposure. It is important to inform patients that if the medication is swallowed, or if it comes into contact with the eyes or ears, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and prompt action in case of an emergency.

Storage and Handling

The product is supplied in a configuration that allows for single use only. It is essential to discard any unused portion after the initial application to ensure safety and efficacy.

Storage conditions require that the product be kept away from excessive heat, with a maximum temperature limit of 40°C (104°F). Proper handling and storage are crucial to maintain the integrity 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 107, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)