Scrub-Stat

Description

SCRUB-STAT™ 4% is an antiseptic foam forming solution containing 4% chlorhexidine gluconate as the active ingredient. This formulation is indicated for use as a surgical hand scrub and healthcare personnel handwash. The product is supplied in a net volume of 25 fluid ounces (750 mL). It is manufactured by Ecolab, located at 1 Ecolab Place, St Paul, MN 55102, USA. The product should be stored in conditions that prevent freezing. SCRUB-STAT™ 4% is produced in the United States. For more information, visit www.ecolab.com. © 2018 Ecolab USA Inc · All rights reserved.

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. Following this, they should dispense 10 pumps (5 grams) of the product into their hands. 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 scrubbing, hands and forearms must be rinsed thoroughly with water.

For a second wash, healthcare professionals should again dispense 10 pumps (5 grams) of the product into their hands and scrub for an additional 3 minutes. This second wash should also be followed by a thorough rinse under running water. Finally, hands and forearms should be dried thoroughly.

For routine handwashing by healthcare personnel, the process begins with wetting the hands with water. Then, 10 pumps (5 grams) of the product should be dispensed into the hands. A vigorous wash should be conducted for 30 seconds, followed by rinsing and thorough drying of the hands.

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 effects in deeper tissue.

Warnings and Precautions

For external use only. This product carries a significant allergy alert, as it may induce severe allergic reactions. Symptoms of such reactions can 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 components of this product should refrain from its use.

When utilizing this product, it is crucial to avoid contact with the eyes, ears, and mouth. Exposure to the eyes may result in serious and permanent injury, while instillation into the middle ear through perforated eardrums may lead to deafness. Should contact with these areas occur, it is essential to rinse thoroughly with cold water without delay.

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

Users should discontinue use and consult a healthcare professional if any signs of irritation, sensitization, or allergic reaction manifest, as these may indicate a serious underlying condition.

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 advised.

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 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 critical 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 the product is instilled in the middle ear through perforated eardrums. Should contact occur, it is recommended to rinse the affected area with cold water promptly.

Patients are also advised to discontinue use 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 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 monitor these patients closely to mitigate potential risks associated with their use.

Geriatric Use

There is no specific information regarding the use of SCRUB-STAT (chlorhexidine gluconate solution) in geriatric patients. The prescribing information does not indicate any dosage adjustments, safety concerns, or special precautions that are specifically applicable to elderly patients. Therefore, healthcare providers should exercise clinical judgment when considering the use of this medication in the geriatric population, as individual patient factors may influence treatment decisions. Monitoring for efficacy and safety is recommended, as with any patient group.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. There are no contraindications noted for use in pregnant patients, nor are there any associated risks to the fetus identified in the available literature. Additionally, no dosage modifications or special precautions for use during pregnancy are mentioned. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

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 these vulnerable populations. It is advisable for healthcare professionals to closely monitor breastfed infants for any adverse effects when this product is used by lactating mothers.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the drug insert. 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 the patient's overall condition.

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, 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 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. Special care should be taken 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 not to use the product if they have a known allergy to chlorhexidine gluconate or any other ingredients contained in the formulation. It is essential to emphasize that while using this product, patients must avoid contact with the eyes, ears, and mouth, as exposure may lead to serious and permanent eye injury or potential deafness if introduced into the middle ear through perforated eardrums.

In the event of accidental contact with these areas, patients should rinse thoroughly with cold water right away. Additionally, healthcare providers should caution patients against routine use of the product on wounds that extend beyond the superficial layers of the skin.

Patients should be instructed to discontinue use and consult a doctor if they experience any irritation, sensitization, or allergic reactions, as these symptoms may indicate a serious condition requiring medical attention.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity. Care must be taken to avoid exposure to excessive heat, defined as temperatures above 104°F (40°C). Additionally, it is crucial to keep the product from freezing to ensure optimal performance and safety.

Additional Clinical Information

The product is intended for topical administration only. Clinicians should counsel patients that it is for external use and may cause severe allergic reactions, which can manifest as wheezing, difficulty breathing, shock, facial swelling, hives, or rash. In the event of an allergic reaction, patients are advised to discontinue use and seek immediate medical assistance.

Patients should be cautioned 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. If contact occurs, rinsing with cold water is recommended. The product should not be used on wounds that extend beyond the superficial layers of the skin. Patients should discontinue use and consult a healthcare provider if irritation, sensitization, or an allergic reaction occurs, as these may indicate a serious condition. Additionally, the product should be kept out of reach of children, and if ingested, medical help or contact with a Poison Control Center should be sought immediately.

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)