Antiseptic Skin Cleanser

Description

No description information is available for the drug.

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. This product is intended for use by healthcare professionals and has been clinically proven to effectively reduce bacteria on the skin.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals are advised to follow the specified procedures for surgical hand scrubs and healthcare personnel handwashing to ensure optimal hygiene.

For the surgical hand scrub, begin by wetting hands and forearms under running water for 30 seconds. Clean fingernails using a nailstick or a similar cleaner. Apply approximately 8 mL of the product (equivalent to 5 full pumps) and scrub for 1.5 minutes, utilizing a wet brush if desired. It is essential to pay close attention to the nails, cuticles, and the skin between the fingers. After scrubbing, rinse thoroughly under running water for 30 seconds. Repeat the process by washing for an additional 1.5 minutes with another 8 mL (5 full pumps) of the product, followed by a final rinse under running water for 30 seconds. Ensure hands are dried thoroughly after completion.

For healthcare personnel handwashing, wet hands with water and dispense approximately 5 mL of the product (about 3 full pumps) into cupped hands. Wash hands vigorously for 15 seconds, ensuring all areas are covered. Rinse thoroughly and dry hands completely.

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 reactions in deeper tissue.

Warnings and Precautions

For external use only. This product carries an allergy alert, as it may induce severe allergic reactions. 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.

In cases of ingestion, prompt medical help should be sought, or contact a Poison Control Center without delay. This product should not be used by individuals with known allergies to chlorhexidine gluconate or any other components 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 come into contact with 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.

Side Effects

Patients using this product should be aware that it is for external use only. There is a significant risk of severe allergic reactions, which may manifest as wheezing or difficulty breathing, shock, facial swelling, hives, or rash. These symptoms require immediate medical attention.

In addition to the aforementioned serious reactions, patients may experience irritation, sensitization, or other allergic reactions. Such reactions could indicate the development of a serious condition and should be evaluated by a healthcare professional. It is essential for patients to monitor for these adverse reactions and seek appropriate care if they occur.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Antiseptic Skin Cleanser (2% chlorhexidine gluconate solution). 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 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 breastfed infants. Therefore, careful consideration and monitoring are advised when administering this product to lactating mothers who are nursing young infants.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, 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, 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 available information.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Monitoring of vital signs and laboratory parameters may be warranted to assess the patient's condition and guide further management.

Healthcare professionals should remain vigilant for potential symptoms that could indicate an overdosage scenario, although specific symptoms have not been detailed. If any concerning signs or symptoms develop, appropriate medical intervention should be sought immediately.

For further guidance, healthcare providers are encouraged to consult local poison control centers or relevant medical authorities to obtain the most current recommendations for managing suspected overdosage cases.

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 revealed that chlorhexidine gluconate may cause severe allergic reactions. Reported symptoms include wheezing, difficulty breathing, shock, facial swelling, hives, and rash. In cases of an allergic reaction, it is advised to discontinue use and seek medical assistance immediately. Additionally, there have been reports of irritation, sensitization, or allergic reactions, which may 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 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 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 should be made aware that they must discontinue use and consult a healthcare professional 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 Antiseptic Skin Cleanser, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)