Antiseptic Skin Cleanser

Description

Chlorhexidine Gluconate 2% Solution is an antiseptic skin cleanser formulated to reduce bacteria on the skin. This product is distributed by C,D,M,A, Inc., located in Novi, MI 48376, USA, and is available in a net weight of 2 fl oz (60 mL) and 8.5 fl oz (250 mL) sizes. It is labeled as a QUALITY CHOICE antiseptic/antimicrobial skin cleaner and is specifically intended for external use only. The formulation is triclosan-free and has received FDA approval.

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. Additionally, it is indicated for healthcare personnel handwashing, 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 adhere to the following guidelines for the proper use of the product in surgical hand scrubs and healthcare personnel handwashing.

For surgical hand scrubbing, the procedure begins with wetting the hands and forearms under running water for 30 seconds. Fingernails should be cleaned using a nailstick or a similar cleaner. Following this, approximately 8 mL of the product should be applied, with or without a wet brush, and scrubbed for 1.5 minutes, ensuring thorough attention to the nails, cuticles, and the skin between the fingers. After scrubbing, the hands and forearms must be rinsed thoroughly under running water for an additional 30 seconds. This is followed by a second application of about 8 mL of the product, which should be scrubbed for another 1.5 minutes before rinsing again under running water for 30 seconds. Finally, hands and forearms should be dried thoroughly.

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

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, due to the potential for adverse effects in deeper tissue.

Warnings and Precautions

For external use only. This product carries an allergy alert, as it may induce a severe allergic reaction in susceptible individuals. Symptoms of such a reaction 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.

The product should not be used by individuals with a known allergy to chlorhexidine gluconate or any other component of the formulation.

When utilizing 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 product is introduced into the eye during surgical procedures, or it may lead to deafness if instilled in the middle ear through perforated eardrums. Should the solution come into contact with these sensitive areas, it must be rinsed out promptly and thoroughly with water.

Routine use of this product is not recommended for wounds that extend beyond the superficial layers of the skin.

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.

In the case of accidental ingestion, immediate medical attention should be sought, or contact with a Poison Control Center is advised.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Notably, there is a potential for severe allergic reactions, which may manifest as wheezing or difficulty breathing, shock, facial swelling, hives, or rash. Individuals with a known allergy to chlorhexidine gluconate or any other ingredient in this product should not use it.

During the use of this product, it is critical to avoid contact with the eyes, ears, and mouth, as exposure to these areas may lead to serious and permanent eye injury or deafness if instilled in the middle ear through perforated eardrums. In the event of contact with these sensitive areas, patients should rinse thoroughly with water.

Patients are advised to discontinue 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. Additionally, the product should not be used routinely on wounds that extend beyond the superficial layers of the skin.

Drug Interactions

Chlorhexidine gluconate skin cleansers may interact with chlorine-releasing products, leading to staining. To mitigate this interaction, it is advised to rinse the skin thoroughly after using chlorhexidine gluconate and to utilize only non-chlorine detergents for cleansing purposes. This precaution helps prevent any adverse cosmetic effects associated with the combination of these substances.

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 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 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 safety and efficacy of the treatment in geriatric patients, taking into account their overall health status and any comorbid conditions that may influence the therapeutic outcome.

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 sufficient information to assess the potential risks or benefits of this medication in pregnant patients. Healthcare professionals should consider the lack of established safety data when prescribing this medication to women of childbearing potential and weigh the potential risks against the clinical need for treatment.

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.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, as the lack of data necessitates careful consideration of potential risks and benefits.

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 may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports have included allergic reactions, which encompass severe manifestations such as wheezing, difficulty breathing, shock, facial swelling, hives, and rash. Additionally, cases of irritation, sensitization, or allergic reactions have been documented, which may suggest the potential for serious conditions. These events were reported voluntarily or through surveillance programs, contributing to the ongoing assessment 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 essential to inform patients not to use the product if they have a known allergy to chlorhexidine gluconate or any other ingredient contained in the formulation.

Patients should be cautioned 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 the solution is instilled in the middle ear through perforated eardrums. In the event of contact with these sensitive areas, patients should be instructed to rinse thoroughly with water as soon as possible.

Additionally, healthcare providers should emphasize that the product should not be used routinely on wounds that extend beyond the superficial layers of the skin. Patients must be informed 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 should be stored at a controlled room temperature of 20-25°C (68-77°F). Care must be taken to avoid exposure to excessive heat, as temperatures above 40°C (104°F) may compromise the integrity of the product. Proper storage conditions are essential to maintain the quality and efficacy of the product throughout its shelf life.

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.

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