Scrub-Stat

Description

SCRUB-STAT 2% is a chlorhexidine gluconate 2% solution antiseptic indicated for use as a surgical hand scrub and healthcare personnel handwash. The product is supplied in a net content 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 a manner that prevents freezing. SCRUB-STAT 2% is produced in the United States. For more information, visit www.ecolab.com. Copyright © 2020 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 following steps to ensure effective antisepsis. Healthcare professionals should first remove all jewelry. Hands and forearms must be wetted with water before dispensing 6 pumps (5 mL) of the product onto the 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. Following this initial scrub, the hands and forearms should be rinsed thoroughly with water.

An additional wash is then required, utilizing another 6 pumps (5 mL) of the product. This second scrub should also last for 3 minutes, after which the hands and forearms must be rinsed under running water. Finally, it is essential to dry the hands and forearms thoroughly.

For healthcare personnel handwashing, the process begins with wetting the hands with water. After wetting, 6 pumps (5 mL) of the product should be dispensed into the hands. A vigorous wash should be conducted for 30 seconds, followed by a thorough rinse and 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 risk of causing a severe allergic reaction. Symptoms indicative of such a reaction 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. Care should be taken to avoid contact with the eyes, ears, and mouth, as exposure 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, this product should not be used routinely on wounds that extend beyond the superficial layers of the skin.

In cases of ingestion, immediate medical help should be sought, or the local Poison Control Center should be contacted.

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.

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 ingredients 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 may lead to serious and permanent eye injury or potential 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.

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, routine use of this product is not recommended for 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 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 use this product with caution due to the potential for irritation or chemical burns. It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Geriatric Use

There is no specific information regarding the use of SCRUB-STAT chlorhexidine gluconate solution in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when administering this product to geriatric patients, as the absence of specific data necessitates careful monitoring and assessment of the patient's response to treatment.

Pregnancy

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been detailed in the prescribing information. There are no dosage modifications recommended for pregnant individuals, nor are there any special precautions regarding its use during pregnancy. Healthcare professionals should continue to evaluate the benefits and risks when prescribing this medication to women of childbearing potential.

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 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 teratogenic effects have been reported in the available data. Similarly, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any additional insights. Furthermore, there is no information available concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

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 that they must not use the product if they are allergic to chlorhexidine gluconate or any other ingredients contained in the formulation. It is essential to emphasize that while using this product, they should 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. In the event of contact with these areas, patients should rinse with cold water immediately.

Additionally, healthcare providers should caution patients against routine use of the product if they have wounds that extend beyond the superficial layers of the skin. Patients should be instructed to stop using the product and consult a doctor if they experience any irritation, sensitization, or allergic reactions, as these 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

The product is intended for topical administration and is for external use only. Clinicians should counsel patients on the potential for severe allergic reactions, which may 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 this may lead to serious and permanent eye injury or deafness if introduced into 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 stop use and consult a healthcare provider if they experience irritation, sensitization, or any allergic reactions, as these may indicate a serious condition. Additionally, the product should be kept out of reach of children, and in case of ingestion, medical help or contact with a Poison Control Center is necessary.

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)