Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%

Description

Maxiclens™ is an antiseptic skin cleanser containing 4% chlorhexidine gluconate, intended for external use only. The product is distributed by Henry Schein Inc., located at 135 Duryea Road, Melville, NY 11747, USA. It is available in a net volume of 128 fluid ounces (1 gallon or 3.785 liters) and is manufactured in the United States.

Care should be taken when using this product, as chlorhexidine gluconate skin cleansers may cause staining if used in conjunction with chlorine-releasing products, such as chlorine bleach. It is recommended to rinse thoroughly and utilize only non-chlorine detergents for laundering or cleaning. Additionally, the product should be kept from freezing to maintain its efficacy. The National Drug Code (NDC) for this product is 0404-0176-09.

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 serves as a skin wound and general skin cleanser, helping to reduce bacteria on the skin.

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

Dosage and Administration

Healthcare professionals should exercise caution when using this product in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. The product should be used at full strength and must not be diluted.

For surgical hand scrubbing, the following procedure should be adhered to: First, remove all jewelry. Wet hands and forearms with water, then apply 5 mL of the product. Scrub hands and forearms for 3 minutes, ensuring particular attention is given to the nails, cuticles, and interdigital spaces. Rinse thoroughly with water. Following this, wash for an additional 3 minutes using another 5 mL of the product and rinse under running water. Finally, dry hands and forearms thoroughly.

For healthcare personnel handwashing, wet hands with water and dispense approximately 5 mL of the product into cupped hands. Wash vigorously for 30 seconds, then rinse and dry thoroughly.

When using the product as a skin wound and general skin cleanser, first rinse the area to be cleansed with water. Apply the minimum amount of product necessary to cover the skin or wound area and wash gently. Rinse thoroughly with water, and then rinse again thoroughly to ensure complete removal of the product.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to chlorhexidine gluconate or any other component of this formulation should not use this product due to the risk of severe allergic reactions.

The product must not be applied in contact with the meninges, as this may lead to serious complications.

Additionally, use in the genital area is contraindicated to prevent potential adverse effects.

Warnings and Precautions

For external use only. This product carries a significant risk of 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.

Individuals should refrain from using this product if they have a known allergy to chlorhexidine gluconate or any other component of the formulation. Additionally, this product should not be applied in contact with the meninges or used in the genital area.

Healthcare professionals should advise patients to discontinue use and consult a physician if any irritation, sensitization, or allergic reaction occurs and persists for 72 hours, as these symptoms may indicate a serious underlying condition.

In cases of ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center without delay.

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 symptoms including wheezing or difficulty breathing, shock, facial swelling, hives, or rash. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

Additionally, patients should stop using the product and consult a healthcare professional if they experience irritation, sensitization, or any allergic reaction that persists for 72 hours, as these symptoms 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 Maxiclens Chlorhexidine Gluconate Liquid Solution, 4% (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 to prevent accidental ingestion. In the event of swallowing, immediate medical assistance 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 consider these safety concerns and ensure appropriate monitoring to mitigate risks associated with the use of this product in vulnerable populations.

Pregnancy

There are no specific statements regarding the use of this product during pregnancy. Currently, there is no information available about safety concerns related to pregnancy, nor are there any dosage modifications recommended for pregnant individuals. Additionally, the text does not include any special precautions regarding the use of this product in pregnant patients. Healthcare professionals should consider the absence of data when advising women of childbearing potential and pregnant patients about the use of this product.

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 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 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 the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring hemodynamic stability. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Additionally, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management strategies tailored to the substance involved in the overdose. Continuous monitoring and supportive care remain the cornerstones of effective management in such scenarios.

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 question.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which may include severe manifestations such as wheezing or difficulty breathing, shock, facial swelling, hives, and rash.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients must be informed not to use this product if they have a known allergy to chlorhexidine gluconate or any other ingredient contained in the formulation. It is crucial to emphasize that this product should not be used in contact with the meninges or in the genital area.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience irritation, sensitization, or an allergic reaction that persists for 72 hours, as these symptoms may indicate a serious condition.

When using this product, patients should be cautioned to avoid contact with the eyes, ears, and mouth, as it may cause serious and permanent eye injury if introduced into the eye during surgical procedures, or may lead to deafness if instilled in the middle ear through perforated eardrums. In case of contact with these areas, patients should rinse with cold water immediately.

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 be avoided unless necessary to reduce the bacterial population of the skin due to an underlying condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, defined as temperatures above 104°F (40°C). For further details regarding safety and handling, please refer to the Safety Data Sheet (SDS).

Additional Clinical Information

The product is administered topically. Clinicians should counsel patients on the importance of discontinuing use and seeking immediate medical assistance if an allergic reaction occurs. It is crucial to keep the product out of reach of children; if ingested, medical help or contact with a Poison Control Center should be sought immediately. Caution is advised when using this product in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns.

Drug Information (PDF)

This file contains official product information for Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)