Antiseptic Skin Cleanser

Description

NDC 68599-5401-2 identifies a 4% Chlorhexidine Gluconate Solution, manufactured by McKesson, designed as an antiseptic skin cleanser. This formulation is intended to reduce the number of microorganisms on the skin prior to surgical procedures or patient care. The product is supplied in a 4 fl oz (118 mL) container and is labeled with the manufacturer number 16-CHG4. It is important to note that the solution is for single use only and should not be reused.

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. It is also indicated for healthcare personnel handwashing, aiding in the reduction of bacteria that may potentially cause disease. Additionally, this drug is utilized for patient preoperative skin preparation, ensuring the skin is adequately prepared prior to surgery. Furthermore, it is indicated for skin wound care and general skin cleansing.

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

Dosage and Administration

Use with caution in premature infants or infants under 2 months of age, as these products may cause irritation or chemical burns.

For healthcare personnel handwashing, the following procedure should be adhered to: Wet hands with water, then dispense approximately 5 mL of the product into cupped hands. Wash hands vigorously for a duration of 15 seconds, ensuring all areas are covered. Rinse hands thoroughly and dry completely.

In the case of patient preoperative skin preparation, the product should be applied liberally to the surgical site. Swab the area for a minimum of 2 minutes, then dry with a sterile towel. This procedure should be repeated for an additional 2 minutes, followed by drying with a sterile towel to ensure proper preparation.

For skin wound and general skin cleaning, it is essential to thoroughly rinse the area to be cleaned with water. Apply the minimum amount of product necessary to adequately cover the skin or wound area, and wash gently. After cleaning, rinse the area thoroughly once more to remove any residual product.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to chlorhexidine gluconate or any other components of this formulation should not use this product due to the risk of allergic reactions.

Contact with the meninges is contraindicated, as it may lead to serious complications.

Application in the genital area is not recommended, as it may cause irritation or adverse effects.

Additionally, this product should not be used as a preoperative skin preparation for the head or face to avoid potential complications associated with its use in these sensitive areas.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should be aware that it may induce severe allergic reactions in some individuals. 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.

The product should not be used by individuals with known allergies to chlorhexidine gluconate or any other components of the formulation. Additionally, it is contraindicated for use in contact with the meninges and should not be applied to the genital area. It is also not recommended for preoperative skin preparation of the head or face.

Care must be taken to avoid contact with the eyes, ears, and mouth, as exposure to these areas may result in serious and permanent eye injury or potential deafness if instilled in the middle ear through perforated eardrums. Should the solution inadvertently contact these sensitive areas, it is essential to rinse thoroughly and promptly with water.

Wounds that extend beyond the superficial layers of the skin should not be routinely treated with this product. Furthermore, repeated general skin cleansing of large body areas is discouraged unless clinically indicated to reduce the bacterial population of the skin due to an underlying condition.

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 condition. It is also crucial to keep this product 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 recommended.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. A severe allergic reaction is a notable concern, with symptoms that 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.

It is critical to avoid using this product in certain situations. Patients should not use it if they are allergic to chlorhexidine gluconate or any other ingredients contained in the formulation. Additionally, the product should not be applied in contact with the meninges, in the genital area, or as a preoperative skin preparation for the head or face.

While using this product, patients must take precautions to prevent contact with the eyes, ears, and mouth, as exposure to these areas may result in serious and permanent eye injury or deafness if instilled in the middle ear through perforated eardrums. Should the solution come into contact with these sensitive areas, it is essential to rinse thoroughly with water. Furthermore, wounds that extend beyond the superficial layers of the skin should not be routinely treated with this product, and repeated general skin cleansing of large body areas should be avoided unless necessary to reduce the bacterial population due to an underlying condition.

Patients are advised to stop 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.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

Packaging & NDC

Below are the non-prescription pack sizes of Antiseptic Skin Cleanser (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 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. It is essential to assess the individual patient's condition and adjust the treatment approach accordingly 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 these vulnerable populations. It is advisable for healthcare professionals to closely monitor breastfed infants for any adverse reactions when this product is used by lactating mothers.

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 individuals 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 drug. 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 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 the event of an allergic reaction, it is advised to discontinue use immediately and seek medical assistance. Additionally, users are encouraged to stop 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.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing, patients should seek medical help or contact a Poison Control Center immediately.

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

When using this product, it is crucial to instruct patients to avoid contact with the eyes, ears, and mouth. Emphasize that exposure to the eyes can result in serious and permanent injury, particularly if the product is used during surgical procedures, and that instillation in the middle ear through perforated eardrums may lead to deafness. If the solution comes into contact with these areas, patients should rinse thoroughly with water as soon as possible.

Additionally, patients should be cautioned against using this product on wounds that extend beyond the superficial layers of the skin, as routine treatment of such wounds is not recommended. It is also important to advise against repeated general skin cleansing of large body areas unless necessary to reduce the bacterial population due to an underlying 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 68-77ºF (20-25°C) to maintain its integrity. Care should be taken to avoid exposure to excessive heat, specifically temperatures above 104°F (40°C), as this may compromise the product's quality. 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 Antiseptic Skin Cleanser, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)