Scrub-Stat

Description

SCRUB-STAT 4% is a 4% solution of Chlorhexidine Gluconate, indicated for use as a surgical hand scrub and healthcare personnel handwash. The product is available in two packaging options: a hand pump (6030447) and a foot pump (6030450). Each container holds a net content of 33.8 fluid ounces (1000 mL). It is essential to store the product in conditions that prevent freezing. SCRUB-STAT 4% is manufactured by Ecolab, located at 1 Ecolab Place, St Paul, MN 55102, USA. The product is made in the United States and is protected under copyright © 2018 Ecolab USA Inc, with all rights reserved. The reference code for this product is 762529/8501/0218.

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 serves as a handwash for healthcare personnel, 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 removal of all jewelry prior to the procedure. Healthcare professionals should begin by wetting their hands and forearms with water, followed by the application of 5 mL of the product. A thorough wash or scrub of the hands and forearms should be performed for a duration of 3 minutes, with particular attention given to the nails, cuticles, and interdigital spaces. After this initial scrub, hands and forearms must be rinsed thoroughly under running water.

Following the rinse, an additional wash with 5 mL of the product is necessary, which should also be conducted for 3 minutes. This second wash should be followed by another thorough rinse under running water. Finally, hands and forearms must be dried thoroughly to complete the surgical hand scrub procedure.

For healthcare personnel handwashing, the process begins with wetting the hands with water. Approximately 5 mL of the product should be dispensed into cupped hands, followed by a vigorous wash for 30 seconds. After washing, hands should be rinsed thoroughly and dried completely to ensure proper hygiene.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other components 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 reactions in deeper tissue.

Warnings and Precautions

For external use only. This product carries a significant risk of causing severe allergic reactions. Symptoms indicative of an allergic response 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 may result in serious and permanent eye injury or potential deafness if introduced into the middle ear through perforated eardrums. Should contact occur, it is essential to rinse the affected area with cold water without delay. Additionally, routine use is not recommended for individuals with wounds that extend beyond the superficial layers of the skin.

In cases of ingestion, immediate medical help should be sought, or the 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 underlying condition.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Notably, 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.

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

During the use of this product, patients should take precautions to avoid contact with the eyes, ears, and mouth, as exposure may lead to serious and permanent eye injury or deafness if instilled in the middle ear through perforated eardrums. Should contact occur, it is recommended to rinse the affected area with cold water promptly.

Additionally, patients are 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, patients should stop using the product and consult a healthcare professional, as these symptoms may indicate a serious condition.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Scrub-Stat (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 consider these risks when prescribing to young infants.

Geriatric Use

Elderly patients should be monitored closely when using this medication, particularly those who are premature infants 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. Regular assessment of the patient's condition and response to treatment is recommended 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 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 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 may impact the drug's efficacy and safety profile in this population. Regular monitoring of renal function is advisable to ensure patient safety.

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 overdose, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should be contacted without delay, or the individual should reach out to a Poison Control Center for guidance.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. It is recommended that healthcare providers assess the situation thoroughly, including the amount ingested and the time of ingestion, to determine the appropriate course of action.

Monitoring for symptoms of overdose is critical, as they may vary depending on the specific substance involved. Healthcare professionals should be prepared to manage any symptoms that arise and provide supportive care as necessary.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available data. Additionally, there is no information regarding nonclinical toxicology or animal pharmacology and toxicology provided in the insert.

Postmarketing Experience

Postmarketing experience has identified the potential for severe allergic reactions associated with this product. Reported symptoms of such reactions may include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, it is advised to discontinue use and seek immediate medical assistance.

Additionally, users are cautioned to stop use and consult a healthcare professional if signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition. The product should be used with caution in premature infants or infants under 2 months of age, as it may lead to irritation or chemical burns.

Patient Counseling

Patients should be advised to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Healthcare providers should inform patients that they should not use this product if they are allergic to chlorhexidine gluconate or any other ingredients contained within it. It is important to emphasize that the product should be kept away from the eyes, ears, and mouth, as contact may lead to serious and permanent eye injury or potential deafness if introduced into the middle ear through perforated eardrums. In case of contact with these areas, patients should rinse with cold water immediately.

Patients should also be cautioned against routine use of the product if they have wounds that extend beyond the superficial layers of the skin. They should be instructed to discontinue use and consult a healthcare professional if they experience any irritation, sensitization, or allergic reactions, as these symptoms may indicate a serious condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25 °C (68-77 °F). Care should be taken to avoid exposure to excessive heat, defined as temperatures above 104 °F (40 °C). Additionally, the product must be protected from freezing to maintain its integrity and efficacy. Proper storage conditions are crucial for ensuring the quality and safety of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)