Scrub-Stat

Description

ECOLAB® SCRUB-STAT™ 2% is a chlorhexidine gluconate 2% solution formulated as an antiseptic foam forming solution. It is designed for use as a surgical hand scrub and healthcare personnel handwash. The product is packaged in a net volume of 25 fluid ounces (750 mL). It is essential to keep the solution from freezing. This product is manufactured in the United States and is distributed by Ecolab, located at 1 Ecolab Place, St Paul, MN 55102, USA. The National Drug Code (NDC) for this product is 47593-467-41. For more information, visit www.ecolab.com. All rights reserved © 2020 Ecolab USA Inc.

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 surgery 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

Healthcare professionals should exercise caution when using this product in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. The product is to be used at full strength and must not be diluted.

For surgical hand scrubs, the following procedure should be adhered to:

1. Remove all jewelry prior to the scrub.

2. Wet hands and forearms with water.

3. Dispense 9 pumps (5 grams) of the product into the hands.

4. Scrub hands and forearms for a duration of 3 minutes, ensuring thorough attention is given to the nails, cuticles, and interdigital spaces.

5. Rinse hands and forearms thoroughly under running water.

6. Repeat the process by dispensing an additional 9 pumps (5 grams) of the product and scrub for another 3 minutes.

7. Rinse again under running water.

8. Dry hands and forearms thoroughly.

For healthcare personnel handwashing, the following steps should be followed:

1. Wet hands with water.

2. Dispense 9 pumps (5 grams) of the product into the hands.

3. Wash hands vigorously for 30 seconds.

4. Rinse hands thoroughly and dry completely.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other component of the formulation. Additionally, the product should not be used routinely in patients with wounds that extend beyond the superficial layers of the skin, as this may pose a risk of adverse effects.

Warnings and Precautions

This product is intended for external use only.

Allergy Alert: The formulation may induce a severe allergic reaction in susceptible individuals. Symptoms of such a reaction 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.

Contraindications: This product should not be used by individuals who are allergic to chlorhexidine gluconate or any other component of the formulation.

Precautions During Use: 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 immediately. Additionally, this product should not be used routinely on wounds that extend beyond the superficial layers of the skin.

Monitoring for Adverse Reactions: Users should discontinue use and consult a healthcare professional if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition.

Safety Precautions: This product must be kept out of reach of children. In the event of accidental ingestion, it is crucial to seek medical help or contact a Poison Control Center without delay.

Side Effects

Patients using this product may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

A severe allergic reaction is a notable risk associated with this product. Symptoms of such a reaction may include 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.

Participants should be aware that this product is contraindicated for individuals with a known allergy to chlorhexidine gluconate or any other ingredient contained in the formulation.

During the use of this product, it is crucial 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.

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 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 closely monitor these patients to mitigate potential risks associated with their use.

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 populations may experience increased sensitivity. The potential for irritation or chemical burns necessitates caution in administration. It is advisable to consider dose adjustments and enhanced monitoring for geriatric patients 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 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. 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 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 are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Prompt action is crucial in mitigating potential adverse effects associated with overdosage. The symptoms may vary depending on the specific substance involved; therefore, a thorough assessment and appropriate treatment plan should be initiated based on the clinical presentation and guidance from poison control experts.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 cases of an allergic reaction, it is advised to discontinue use immediately and seek 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 the medication out of reach of children. In the event that the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately.

Additionally, patients should be instructed to discontinue use and consult a doctor if they experience any irritation, sensitization, or signs of an allergic reaction. These symptoms may indicate a serious condition that requires medical attention.

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) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, defined as temperatures above 104°F (40°C), as well as to prevent freezing. Proper storage conditions are crucial to ensure the integrity and stability of the product throughout its shelf life.

Additional Clinical Information

The product is administered topically. Clinicians should advise patients to use the product with caution in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. It is crucial to avoid contact with the eyes, ears, and mouth, as exposure can lead to serious and permanent eye injury or deafness if instilled in the middle ear through perforated eardrums. In the event of contact, patients should rinse the affected area with cold water immediately.

Patients are also cautioned against routine use on wounds that extend beyond the superficial layers of the skin. They should discontinue use and consult a healthcare professional if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition. Additionally, the product should be kept out of reach of children, and immediate medical assistance should be sought if ingested.

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)