Cardinal Health Antiseptic Skin Cleanser

Description

Chlorhexidine Gluconate 2% Solution is a non-sterile antiseptic formulation available in two sizes: 4 fluid ounces (118 mL) and 8 fluid ounces (237 mL). This solution is intended for single use and serves as an effective antiseptic agent.

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 preparation of the patient's skin prior to surgical procedures. Furthermore, it is indicated for skin wound and general skin cleansing.

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

Dosage and Administration

Surgical hand scrub requires the operator to first wet hands and forearms under running water for 30 seconds. Fingernails should be cleaned using a nailstick or similar cleaner. Following this, 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. The hands and forearms must then be rinsed thoroughly under running water for 30 seconds. This process should be repeated by washing for an additional 1.5 minutes with another 8 mL of product, followed by another 30-second rinse under running water. Finally, hands and forearms should be dried thoroughly.

For healthcare personnel handwashing, the individual should wet their hands with water and dispense about 5 mL of the product into cupped hands. A vigorous wash should be performed for 15 seconds, followed by rinsing and thorough drying of the hands.

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 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. A thorough rinse should be performed again to ensure complete cleansing.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to chlorhexidine gluconate or any other ingredient in this formulation should not use this product due to the risk of severe 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

For external use only. This product carries a significant risk of causing severe allergic reactions. Symptoms indicative of such reactions 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. The product should be kept away from the eyes, ears, and mouth, as contact with these areas may result in serious and permanent eye injury or potential deafness if introduced into the middle ear through perforated eardrums. Should the solution inadvertently contact these sensitive areas, it is essential to rinse thoroughly with water without delay. Additionally, wounds that extend beyond the superficial layers of skin should not be treated routinely with this product. Repeated cleansing of large body areas is discouraged unless specifically recommended by a healthcare provider.

In cases of ingestion, immediate medical help should be sought, or a Poison Control Center should be contacted without delay.

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 using this product should be aware of the potential for serious adverse reactions, particularly severe allergic reactions. Symptoms of such reactions 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.

This product is contraindicated for use in individuals with a known allergy to chlorhexidine gluconate or any other ingredient contained in the formulation. It should not be applied in contact with the meninges, in the genital area, or utilized as a preoperative skin preparation for the head or face.

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 the solution come into contact with these areas, it is imperative to rinse thoroughly with water. Additionally, wounds that extend beyond the superficial layers of skin should not be treated routinely with this product, and repeated general skin cleansing of large body areas should only be performed under the guidance of a healthcare provider.

Patients should discontinue use and consult a physician if they experience irritation, sensitization, or any signs of an allergic reaction, as these 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 or under 2 months of age, as these populations may experience increased sensitivity. The potential for irritation or chemical burns necessitates caution in administration.

Healthcare providers are advised to assess the risks and benefits of treatment in geriatric patients, ensuring that appropriate safety measures are in place. Regular monitoring for adverse effects is recommended to mitigate any potential complications associated with the use of this medication in the elderly population.

Pregnancy

Pregnant patients should be aware that the safety of this medication during pregnancy has not been specifically established. There are no explicit statements regarding safety concerns during pregnancy, and no dosage modifications are provided for pregnant individuals. Additionally, there are no special precautions mentioned regarding the use of this medication in pregnant patients. Healthcare professionals should weigh the potential benefits against any unknown risks when considering this medication for 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 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 prudent 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, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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

Serious side effects have been reported voluntarily or 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 ongoing safety monitoring and evaluation of the product.

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 product away from 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.

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.

Patients should be made aware that repeated general skin cleansing of large body areas should only be performed when specifically advised by a healthcare provider. Additionally, they should be instructed to discontinue use and consult a doctor if they experience any irritation, sensitization, or allergic reactions, 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 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 Cardinal Health Antiseptic Skin Cleanser, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)