Antiseptic Skin Cleanser

Description

Chlorhexidine Gluconate 2% Solution is an antiseptic formulation designed for external use only. This product is available under the Quality Choice® brand and is presented in a net weight of 2 fluid ounces (60 mL) as well as an 8.5 fluid ounce (250 mL) option. It serves as an antiseptic skin cleanser, effectively reducing bacteria on the skin. The formulation is triclosan-free and has received FDA approval, ensuring its compliance with regulatory standards for safety and efficacy.

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 are advised to follow the specified procedures for the surgical hand scrub and healthcare personnel handwash to ensure optimal hygiene and infection control.

For the surgical hand scrub, the following steps should be adhered to:

1. Wet hands and forearms under running water for 30 seconds.

2. Clean fingernails using a nailstick or a similar cleaner.

3. Dispense approximately 8 mL of product (equivalent to 5 full pumps) and scrub for 1.5 minutes. This can be done with or without a wet brush, ensuring thorough attention to the nails, cuticles, and the skin between the fingers.

4. Rinse hands and forearms thoroughly under running water for 30 seconds.

5. Repeat the scrubbing process for an additional 1.5 minutes using another 8 mL of product (5 full pumps), followed by a thorough rinse under running water for 30 seconds.

6. Dry hands and forearms thoroughly.

For the healthcare personnel handwash, the following procedure is recommended:

1. Wet hands with water.

2. Dispense approximately 5 mL of product (equivalent to 3 full pumps) into cupped hands.

3. Wash hands vigorously for about 15 seconds.

4. Rinse hands thoroughly and dry completely.

Adhering to these protocols is essential for maintaining hand hygiene in clinical settings.

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, as this may pose a risk of adverse effects.

Care should be taken to avoid contact with the eyes, ears, and mouth, as exposure may result in serious and permanent eye injury or deafness if introduced into the middle ear through perforated eardrums. In the event of contact with these areas, it is imperative to rinse thoroughly with water.

Discontinue use and consult a healthcare professional if irritation, sensitization, or an allergic reaction occurs, as these may indicate a serious condition.

Warnings and Precautions

For external use only. This product carries a significant 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 or potential deafness if the solution is instilled into the middle ear through perforated eardrums. Should the solution inadvertently contact these sensitive areas, it is essential to rinse thoroughly and promptly with water.

Routine use of this product is not recommended for individuals with 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 cases of accidental ingestion, immediate medical attention should be sought, or contact with a Poison Control Center is advised.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to allergic responses. The product is for external use only and may cause 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, patients are advised to discontinue use immediately and seek medical assistance.

Patients with a known allergy to chlorhexidine gluconate or any other ingredient in this product should not use it. Caution is also advised during application; the product should be kept out of the eyes, ears, and mouth, as contact with these areas 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 sensitive areas, it is imperative to rinse thoroughly with water.

Additionally, patients are instructed to stop using the product and consult a healthcare professional if they experience irritation, sensitization, or any signs of an allergic reaction, as these may indicate a serious condition. It is also recommended that the product 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. 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 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 may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of chlorhexidine gluconate during pregnancy. The available prescribing information does not mention any safety concerns, contraindications, or special precautions associated with the use of this product in pregnant patients. Additionally, no dosage modifications for pregnant individuals are indicated. As such, healthcare professionals should consider the absence of specific data when advising women of childbearing potential regarding the use of chlorhexidine gluconate during pregnancy.

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 effects 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 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 individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. Notable among these are allergic reactions, which may include severe manifestations such as wheezing, difficulty breathing, shock, facial swelling, hives, and rash. Additionally, instances of irritation, sensitization, or allergic reactions have been observed, which could indicate the presence of a serious condition.

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 contact with these areas may lead to serious and permanent eye injury or potential deafness if instilled in the middle ear through perforated eardrums.

In the event of accidental contact with the eyes, ears, or mouth, patients should be instructed to rinse the affected area promptly and thoroughly with water. Providers should also caution patients against routine use of the product if they have wounds that extend beyond the superficial layers of the skin.

Patients must be made aware that they should 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, specifically temperatures exceeding 40°C (104°F), to maintain product integrity. Proper container requirements should be adhered to, ensuring that the product is kept in suitable conditions to prevent degradation. Special handling needs should be observed to ensure the product remains within the recommended temperature range throughout its storage and handling processes.

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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