Scrub

Description

NDC 61037-412-01. SCRUB™ is an FDA-approved antiseptic handwash formulated with 0.75% chlorhexidine gluconate. This solution is intended for external use only and is distributed by Bajaj Medical, LLC, located at 415 W. Pershing Rd., Chicago, IL 60609. The product is available in a net volume of 4 fl oz (118 ml).

Uses and Indications

This drug is indicated for use in healthcare personnel handwashing to help reduce bacteria that potentially can cause disease.

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

Dosage and Administration

Healthcare professionals are advised to exercise caution when administering this product to premature infants and infants under 2 months of age, as it may cause irritation or chemical burns.

For hand hygiene, healthcare personnel should follow these steps to ensure effective use of the product:

1. Wet hands thoroughly with water.

2. Dispense approximately 5 ml of the product into cupped hands.

3. Wash hands vigorously for a duration of 30 seconds, ensuring all surfaces are covered.

4. Rinse hands thoroughly under running water and dry completely.

Adhering to these guidelines will help maintain safety and efficacy during administration.

Contraindications

Use of this product is contraindicated in the following situations:

• Known allergy to chlorhexidine gluconate or any other components of the formulation.

• Contact with the meninges, due to the risk of serious complications.

• Application in the genital area, as it may cause irritation or adverse effects.

• Use as a preoperative skin preparation, particularly on the head and face, to avoid potential complications.

• Application on skin wounds, as it may impede healing or cause irritation.

• Use as a general skin cleanser or surgical hand scrub, as it is not intended for these purposes.

Warnings and Precautions

For external use only. This product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other ingredients contained in the formulation. It should not be applied in contact with the meninges, the genital area, or used as a preoperative skin preparation, particularly on the head and face. Additionally, it is not intended for application on skin wounds or as a general skin cleanser for surgical hand scrubbing.

When utilizing this product, it is imperative to avoid contact with the eyes, ears, and mouth. Exposure to these areas may result in serious and permanent eye injury if the solution is introduced or retained in the eye during surgical procedures. Furthermore, instillation into the middle ear through perforated eardrums may lead to deafness. Should the solution inadvertently contact these sensitive areas, it is essential to rinse thoroughly and promptly with water.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition.

This product must be kept 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 recommended.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other ingredients contained in the formulation. The product should not be used in contact with the meninges, in the genital area, as a preoperative skin preparation—particularly on the head and face—or on skin wounds. Additionally, it is not intended for use as a general skin cleanser or surgical hand scrub.

During the use of this product, it is crucial to avoid contact with the eyes, ears, and mouth. Exposure to these areas may result in serious and permanent eye injury if the solution is placed or retained in the eye during surgical procedures. Furthermore, instillation in the middle ear through perforated eardrums may lead to deafness. Should the solution come into contact with these sensitive areas, it is imperative to rinse thoroughly and promptly with water.

Patients are advised to discontinue use and consult a healthcare professional if they experience irritation, sensitization, or any allergic reactions, as these may indicate a serious condition.

It is important to note that this product contains a chemical recognized by the State of California as a potential carcinogen.

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 (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

Elderly patients should be monitored closely when using this product, particularly those who are premature or under 2 months of age, as there is a risk of irritation or chemical burns associated with its use. Caution is advised in this population, and healthcare providers should consider the potential for increased sensitivity and adverse reactions. It is essential to assess the individual needs and health status of geriatric patients to ensure safe and effective use.

Pregnancy

There are no specific statements regarding the use of chlorhexidine gluconate solution during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, the available data does not provide clear guidance on the potential risks or fetal impacts associated with its use in pregnant patients. Healthcare professionals should consider the lack of information when advising women of childbearing potential and weigh the benefits against any potential risks when prescribing this solution during pregnancy.

Lactation

Lactating mothers should use this product with caution, particularly in the case of premature infants and infants under 2 months of age. There is a risk that these products 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance 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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is recommended to ensure optimal patient care and 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 question.

Postmarketing Experience

Postmarketing experience has identified that this product contains a chemical recognized by the State of California as a potential carcinogen. Additionally, caution is advised when using this product in premature infants and infants under 2 months of age, as it may lead to irritation or chemical burns.

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 crucial to emphasize the importance of keeping the solution away from the eyes, ears, and mouth, as exposure to these areas may result in serious and permanent eye injury if the solution is placed or retained in the eye during surgical procedures. Additionally, instillation in the middle ear through perforated eardrums may lead to deafness.

In the event that the solution comes into contact with the eyes, ears, or mouth, patients should be instructed to rinse the affected area promptly and thoroughly with water. This guidance is essential to minimize potential harm and ensure patient safety.

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 controlled temperature range of 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), to maintain product integrity. Proper storage conditions are crucial for ensuring the efficacy and safety of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)