Scrub Care

Description

BD Scrub Care™ is a non-sterile antiseptic solution containing 4% Chlorhexidine Gluconate. The product is intended for external use only and is provided in a single-use format. Each container holds a net volume of 4 fluid ounces (118 mL). The product is distributed by Becton, Dickinson and Company, located in Vernon Hills, IL 60061, USA. The National Drug Code (NDC) for this product is 0116-2994.

Uses and Indications

This drug is indicated for surgical hand scrub to significantly reduce the number of microorganisms on the hands and forearms prior to surgery or patient care. It is also indicated for healthcare personnel hand washing to help reduce bacteria that may potentially cause disease. Additionally, this drug is used for patient preoperative skin preparation, ensuring the skin is adequately prepared prior to surgical procedures. Furthermore, it is indicated for skin wound and general skin cleansing.

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

Dosage and Administration

Surgical hand scrub requires the operator to first wet the arms and forearms with water. Approximately 5 ml of the product should be used in conjunction with a wet brush to scrub for a duration of 3 minutes, ensuring meticulous attention is given to the nails, cuticles, and interdigital spaces. A separate nail cleaner may be utilized if necessary. Following the initial scrub, the hands must be rinsed thoroughly. The procedure should then be repeated for an additional 3 minutes using another 5 ml of the product, followed by rinsing under running water. It is essential to dry the hands thoroughly after completion.

For healthcare personnel handwashing, the hands should be wetted with water before dispensing about 5 ml of the product into cupped hands. A vigorous washing technique should be employed for a minimum of 15 seconds, after which the hands must be rinsed and dried thoroughly.

In the context of patient preoperative skin preparation, the product should be applied liberally to the surgical site. The area must be swabbed for at least 2 minutes, followed by drying with a sterile towel. This procedure should be repeated for an additional 2 minutes, concluding with drying using a sterile towel.

For skin wound and general skin cleansing, the area to be cleaned should be thoroughly rinsed with water. The minimum amount of product necessary to adequately cover the skin or wound area should be applied, followed by gentle washing. A thorough rinse is required to complete the cleansing process.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to chlorhexidine gluconate or any other component of this formulation should not use this product due to the risk of severe allergic reactions.

Contact with the meninges is contraindicated, as it may lead to serious complications.

Application in the genital area is not recommended, as it may cause irritation or adverse effects.

Additionally, this product should not be used as a preoperative skin preparation for the head or face to avoid potential complications associated with its use in these sensitive areas.

Warnings and Precautions

For external use only. This product carries a significant risk of causing severe allergic reactions. Symptoms indicative of such reactions may include wheezing, 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 permanent eye injury or potential 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.

Wounds that extend beyond the superficial layers of the skin should not be treated routinely with this product. Additionally, repeated cleansing of large body areas should be avoided unless specifically advised by a healthcare provider.

In cases of ingestion, immediate medical help should be sought, or a Poison Control Center should be contacted without delay.

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.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious. A notable concern is the potential for severe allergic reactions, which may manifest as wheezing, shock, facial swelling, hives, or rash. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

The product is contraindicated in individuals with known allergies to chlorhexidine gluconate or any other component of the formulation. It should not be used in contact with the meninges, in the genital area, or as a preoperative skin preparation for the head or face.

During use, it is crucial 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 advised to rinse thoroughly with water.

Patients should refrain from using this product on wounds that penetrate beyond the superficial layers of the skin, and repeated general skin cleansing of large body areas should only be performed under the guidance of a healthcare provider.

If irritation, sensitization, or any signs of an allergic reaction occur, patients are advised to stop use and consult a physician, as these symptoms may indicate a serious condition. Additionally, if the product is ingested, immediate medical attention 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 Scrub Care (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. There is a risk of irritation or chemical burns associated with its use in this population. Healthcare professionals are advised to closely monitor these patients to mitigate potential adverse effects.

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 individuals may experience irritation or chemical burns. Caution is advised in this population due to the potential for increased sensitivity to the effects of the medication. It is essential for healthcare providers to assess the risks and benefits of treatment in geriatric patients, ensuring appropriate dosage adjustments and safety considerations are taken into account. Regular monitoring for adverse effects is recommended to mitigate any potential complications associated with use in this demographic.

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 text. 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Similarly, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Additionally, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions, such as anaphylaxis, and various skin reactions, including rash, pruritus, and urticaria. Additionally, reports of serious skin reactions, including chemical burns, have been received.

There have also been cases of eye injury associated with contact of the solution with the eyes. Furthermore, instances of ototoxicity have been reported when the solution was instilled in the middle ear through perforated eardrums.

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 cautioned against using the product in contact with the meninges, the genital area, or as a preoperative skin preparation for the head or face. Providers should emphasize the importance of discontinuing use and consulting a physician if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition.

When instructing patients on the proper use of the product, healthcare providers should stress the necessity of keeping the solution away from 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. In the event of contact with these sensitive areas, patients should rinse thoroughly and promptly with water.

Providers should also inform patients that wounds involving more than the superficial layers of the skin should not be routinely treated with this product. Additionally, repeated general skin cleansing of large body areas should only be performed when specifically advised by a healthcare provider.

Storage and Handling

The product is supplied for external use only and is intended for single use. It should be stored at a temperature range of 20-25ºC (68-77ºF). Care should 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 route of administration for the product is topical. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)