Cardinal Health Antiseptic Skin Cleanser

Description

Chlorhexidine Gluconate is presented as a 2% solution, available in two packaging sizes: 4 fl oz (118 mL) and 8 fl oz (237 mL). This non-sterile solution serves as a single-use antiseptic. It is distributed by Cardinal Health, located in Waukegan, IL 60085, USA. The product is identified by the National Drug Code (NDC) 63517-113-04 for the 4 fl oz size and NDC 63517-113-08 for the 8 fl oz size.

Uses and Indications

This drug is indicated for surgical hand scrub to significantly reduce the number of microorganisms on the hands and forearms prior to surgery or patient care. It is also indicated for healthcare personnel handwash, aiding in the reduction of bacteria that may potentially cause disease. Additionally, this drug is utilized for patient preoperative skin preparation, ensuring the patient's skin is adequately prepared prior to surgical procedures. Furthermore, it is indicated for skin wound and general skin cleansing.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Surgical hand scrub requires the following steps: First, healthcare professionals should wet their hands and forearms under running water for 30 seconds. Fingernails must be cleaned using a nailstick or similar cleaner. Next, approximately 8 mL of the product should be scrubbed for 1.5 minutes, with or without a wet brush, ensuring thorough attention to the nails, cuticles, and skin between the fingers. After scrubbing, hands should be rinsed thoroughly under running water for 30 seconds. This process should be repeated with an additional 8 mL of product, followed by another 30-second rinse under running water. Finally, hands must be dried thoroughly.

For healthcare personnel handwashing, the procedure begins with wetting the hands with water. About 5 mL of the product should be dispensed into cupped hands, followed by vigorous washing for 15 seconds. After washing, hands should be rinsed and dried thoroughly.

In the case of patient preoperative skin preparation, the product should be applied liberally to the surgical site. The area must be swabbed for at least 2 minutes and then dried with a sterile towel. This procedure should be repeated for an additional 2 minutes, followed by drying with another sterile towel.

For skin wound and general skin cleansing, the area to be cleaned should first be thoroughly rinsed with water. The minimum amount of product necessary to cover the skin or wound area should then be applied, followed by gentle washing. The area must be rinsed thoroughly again to complete the cleansing process.

Contraindications

Use of this product is contraindicated in the following situations:

• Patients with a known allergy to chlorhexidine gluconate or any other components of the formulation.

• Application in contact with the meninges is contraindicated due to the risk of serious adverse effects.

• Use in the genital area is not recommended to avoid potential irritation or adverse reactions.

• The product should not be utilized as a preoperative skin preparation for the head or face to prevent complications associated with its use in these sensitive areas.

Warnings and Precautions

For external use only. This product carries a significant risk of severe allergic reactions. Healthcare professionals should be vigilant for symptoms such as wheezing, difficulty breathing, shock, facial swelling, hives, or rash. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare providers should advise patients to stop using the product and consult a physician if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious underlying condition. In cases of ingestion, immediate medical attention should be sought, or the local Poison Control Center should be contacted.

It is crucial to avoid contact with the eyes, ears, and mouth, as exposure may lead to serious and permanent eye injury if the product is introduced into the eye during surgical procedures. Additionally, instillation into the middle ear through perforated eardrums may result in deafness. Should the solution come into contact with these sensitive areas, it is essential to rinse thoroughly with water.

Wounds that extend beyond the superficial layers of skin should not be treated with this product routinely. Furthermore, repeated general skin cleansing of extensive body areas is discouraged unless necessitated by the underlying condition to reduce the bacterial load on the skin.

Side Effects

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

Severe allergic reactions have been reported, which may manifest as wheezing or difficulty breathing, shock, facial swelling, hives, or rash. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance. It is crucial to note that this product should not be used by individuals with a known allergy to chlorhexidine gluconate or any other ingredients contained in the formulation.

In clinical settings, caution is advised as the product should not come into contact with the meninges or be applied in the genital area. Additionally, it is contraindicated for use as a preoperative skin preparation on the head or face.

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

Patients should also refrain from using this product on wounds that penetrate beyond the superficial layers of skin, and repeated general skin cleansing of large body areas should only be performed when necessary to reduce the bacterial population due to an underlying condition.

If irritation, sensitization, or any signs of an allergic reaction occur, patients are advised to stop using the product and consult a healthcare professional, as these symptoms may indicate a serious condition.

Drug Interactions

Chlorhexidine gluconate skin cleansers may interact with chlorine-releasing products, including chlorine bleach, leading to staining. It is advised to rinse the skin thoroughly after use and to utilize only non-chlorine detergents to prevent this interaction.

Packaging & NDC

Below are the non-prescription pack sizes of Cardinal Health Antiseptic Skin Cleanser (chlorhexidine gluconate 2%). 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. Regular assessment of the patient's condition and response to treatment is recommended to ensure safety and efficacy.

Pregnancy

The available data does not specifically address the use of this medication during pregnancy. There are no explicit safety concerns outlined in the prescribing information regarding its use in pregnant patients. Additionally, no dosage modifications for pregnant individuals are provided, nor are there any special precautions mentioned for use during pregnancy. Healthcare professionals should consider the lack of specific data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

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 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 there is no available data to guide appropriate dosing or monitoring in this population.

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, 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 patient's clinical presentation. Continuous evaluation and appropriate interventions should be implemented as necessary to ensure patient safety and recovery.

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

Serious side effects have been reported voluntarily or identified through surveillance programs. Healthcare professionals and patients are encouraged to report any serious adverse events to the designated contact number, 1-877-227-3462. This information contributes to the ongoing monitoring of the product's safety profile.

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 inform patients to keep the solution away from the eyes, ears, and mouth, as exposure to these areas may result in serious and permanent eye injury or deafness, particularly if instilled in the middle ear through perforated eardrums.

In the event of contact with the eyes, ears, or mouth, patients should be instructed to rinse the affected area promptly and thoroughly with water. Providers should also counsel patients that wounds involving more than the superficial layers of skin should not be routinely treated with this product.

Additionally, patients should be made aware that repeated general skin cleansing of large body areas is not recommended unless necessary to reduce the bacterial population due to an underlying condition. It is important to inform patients to discontinue use and consult a doctor if they experience irritation, sensitization, or an allergic reaction, as these symptoms 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, 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 Cardinal Health Antiseptic Skin Cleanser, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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