Antiseptic Skin Cleanser

Description

Maxiclens is an antiseptic skin cleanser containing 4% chlorhexidine gluconate. This formulation is intended for external use only. The product is available in a net volume of 32 fluid ounces (1 quart or 946 milliliters). Maxiclens is manufactured in the United States and is distributed by Henry Schein Inc., located at 135 Duryea Road, Melville, NY 11747, USA.

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. Additionally, this drug is suitable for skin wound and general skin cleansing.

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

Dosage and Administration

Surgical hand scrubbing requires the following procedure: Healthcare professionals should begin by wetting their hands and forearms with water. Approximately 5 mL of the product should be applied using a wet brush, ensuring a thorough scrub for 3 minutes, with particular attention to the nails, cuticles, and interdigital spaces. A separate nail cleaner may be utilized if necessary. After scrubbing, the hands and forearms must be rinsed thoroughly. This should be followed by an additional wash for 3 minutes using another 5 mL of the product, which should also be rinsed under running water. Finally, hands and forearms should be dried thoroughly.

For healthcare personnel handwashing, the process 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 must be rinsed and dried thoroughly.

When performing 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. Afterward, the area must be rinsed again thoroughly to ensure complete cleansing.

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 applied in contact with the meninges due to the potential for serious adverse effects. It is also contraindicated for use in the genital area to prevent irritation or other complications.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should be aware of the potential for severe allergic reactions associated with its use. Symptoms indicative of an allergic 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.

In cases where the product is ingested, it is crucial to obtain emergency medical help or contact a Poison Control Center without delay.

Healthcare providers should advise patients to stop using the product and consult their physician if they experience any signs of irritation, sensitization, or an allergic reaction, as these may indicate a serious underlying condition. Monitoring for these adverse effects is essential to ensure patient safety and appropriate management.

Side Effects

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

In the event of irritation, sensitization, or any signs of an allergic reaction, patients are advised to discontinue use immediately 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. The combination of these agents can lead to staining of the skin. To mitigate this risk, it is advised to rinse the skin thoroughly after using chlorhexidine gluconate and to utilize only non-chlorine detergents for cleaning purposes.

Packaging & NDC

Below are the non-prescription pack sizes of Antiseptic Skin Cleanser (chlorhexidine gluconate 4%). 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 monitor these patients closely 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 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. It is essential to assess the individual patient's condition and adjust the treatment approach accordingly to ensure safety and efficacy.

Pregnancy

The use of this medication during pregnancy has not been specifically addressed in the available data. There are no explicit safety concerns noted for pregnant patients, nor are there any dosage modifications recommended for this population. Additionally, no special precautions regarding the use of this medication during pregnancy have been provided. Healthcare professionals should consider the potential risks and benefits when prescribing this medication to women of childbearing potential and during pregnancy, as individual circumstances may vary.

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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, alterations in vital signs, neurological changes, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may include the following steps:

1. Assessment: Conduct a thorough evaluation of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide symptomatic treatment as necessary, which may involve intravenous fluids, oxygen supplementation, or other interventions based on the patient's condition.

3. Decontamination: If the overdose is recent and the patient is alert and able to protect their airway, consider activated charcoal to limit further absorption of the substance.

4. Consultation: Engage with a poison control center or toxicology expert for guidance on specific antidotes or advanced management strategies, if applicable.

Healthcare professionals should remain vigilant and prepared to implement these measures promptly to mitigate the potential effects of an overdose.

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 the potential for severe allergic reactions associated with this product. Reported symptoms of such reactions may include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, it is advised to discontinue use and seek immediate medical assistance.

Additionally, users are cautioned to stop use and consult a healthcare professional if signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition. Special care should be taken when using this product in premature infants or infants under 2 months of age, as it may lead to irritation or chemical burns.

Furthermore, it is important to note that this product contains coconut oil diethanolamine condensate (cocamide diethanolamine), which is recognized by the State of California as a substance that may cause cancer.

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 against using the product in contact with the meninges or in the genital area. They must be instructed to discontinue use and consult a healthcare professional if they experience any irritation, sensitization, or allergic reactions, as these may indicate a serious condition.

When using this product, patients should be reminded to avoid contact with the eyes, ears, and mouth, as exposure may lead to serious and permanent eye injury or potential deafness if the solution enters the middle ear through a perforated eardrum. In the event of contact with these areas, patients should rinse thoroughly and promptly with water.

Healthcare providers should also inform patients that wounds involving more than the superficial layers of the skin should not be routinely treated with this product. Additionally, repeated general skin cleansing of large body areas should only be performed when specifically advised by a healthcare provider.

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.

View product document (PDF)